Electrosurgical devices, electrosurgical unit and methods of use thereof

ABSTRACT

A cartridge assembly to couple an electrosurgical device to treat tissue with an electro surgical unit includes a cartridge member to operate with a power delivery apparatus of the electro surgical unit and a fluid delivery apparatus of the electro surgical unit. An electrosurgical unit includes a power delivery apparatus and a fluid delivery apparatus arranged to operate with a cartridge member to be located in a cartridge receptacle of the electrosurgical unit. An electrosurgical device includes a first electrode spaced alongside the second electrode, with each electrode having a blade shaped member. Each blade shaped member has opposing sides bounded by edges, with the edges having a medial edge and a lateral edge. At least one fluid outlet is adjacent each blade shaped member, and each fluid outlet is in fluid communication with a fluid passage. The device can be operated as either a bipolar device or a monopolar device and includes a switch to inhibit capacitive coupling to one of the electrodes when the other electrode is used in monopolar fashion.

This application is a continuation of U.S. application Ser. No.14/593,312, filed Jan. 9, 2015, now U.S. Pat. No. 9,943,356, issued Apr.16, 2018, which is in turn a divisional of U.S. application Ser. No.13/006,940, filed Jan. 14, 2011, now U.S. Pat. No. 9,050,113, issued onJun. 9, 2015, entitled ELECTROSURGICAL DEVICES, ELECTROSURGICAL UNIT ANDMETHODS OF USE THEREOF, which claims the benefit of U.S. ProvisionalPatent Application No. 61/295,513, entitled ELECTRO SURGICAL DEVICES,ELECTROSURGICAL UNIT AND METHODS OF USE THEREOF, filed on Jan. 15, 2010,the entireties of which are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

This invention relates generally to the field of medical devices,systems and methods for use upon a human body during surgery. Moreparticularly, the invention relates to electro surgical devices, systemsand methods that provide for cutting of tissue in addition tocoagulation, hemostasis, and sealing of tissue to inhibit blood andother fluid loss during surgery, such as abdominal, orthopedic, head,spine and thoracic surgery as well as general surgery of the body.

BACKGROUND OF THE INVENTION

U.S. Patent Application Publication 2002/0198519 published Dec. 26,2002, in the name of Qin et al. discloses an integrated device having aradio frequency generator 38, controller 52 with I/O device 54, and afluid delivery apparatus 44 (e.g., for the delivery of cooling liquid)are integrated within a single housing 400. Electrical connection of adisclosed treatment device 26 a 126 b to the integrated device isperformed by connecting an electrical connector 408 of the treatmentdevice 26 a 126 b to electrical connector 402 of the integrated device.Device 26 a 126 b can also be separately connected via tubing 12 to thefluid delivery apparatus 44, to convey processing fluid for discharge byor near an operative element 36 a 136 b.

From Qin et al., since the connection of electrical connector 408 toelectrical connector 402 and tubing 12 to fluid delivery apparatus 44are performed separately as separate steps and not integrated, the timefor preparing the system for use may be increased or delayed if oneindividual is preparing the system, or two individuals may be requiredto prepare the system if the electrical connection and fluid connectionare to be preformed simultaneously.

In addition, as shown in Qin et al., fluid delivery apparatus 44includes a pump rotor 428. As indicated, the physician can couple thesource of cooling liquid to the appropriate port on the handle of thedevice 26 a 126 b and load the tubing leading from the source of coolingliquid (e.g., a bag containing sterile water) in the pump rotor 428.However, it may be possible to install the tubing improperly, forexample, in the wrong direction (i.e. backwards) in such a way that thepump rotor 428 pumps fluid towards the source of cooling liquid ratherthan device 26 a 126 b. Furthermore, even if the direction of the tubingis proper, it may be possible to misalign the tubing with the pump rotor428 such that the rotor 428 does not interact properly with the tubingcausing a restriction in fluid flow, such as by improperly pinching thetubing, or even damaging the tubing, such as causing a leak. Also, iffluid is introduced into the tubing 12 before the tubing 12 is installedin fluid delivery apparatus 44 it may be possible for the fluid to flowuninhibited through the tubing and leak from treatment device 26 a 126b. As a result, the foregoing installation errors, set-up and use of theequipment may be further delayed.

In light of the above, what is needed is a structure, method and systemin which a medical device to treat tissue can be connected to a powerdelivery apparatus, such as a radio-frequency generator, and a fluiddelivery apparatus, such as a pump, while overcoming the aforementioneddeficiencies in the art, and may enable a single individual to connectthe device to both of the power delivery apparatus and fluid deliveryapparatus substantially simultaneously and without installation error toexpedite use thereof.

SUMMARY OF THE INVENTION

In one embodiment, the invention provides source equipment for use witha device to treat tissue, with the source equipment comprising a powerdelivery apparatus to deliver power provided from a power source to thetissue treatment device and a fluid delivery apparatus to deliver afluid provided from a fluid source to the tissue treatment device. Thepower delivery apparatus and the fluid delivery apparatus are arrangedto operate with a cartridge member to be placed in a cartridgereceptacle of the source equipment.

The source equipment may comprise an electrosurgical unit and the tissuetreatment device may further comprise an electro surgical device.

The power delivery apparatus may comprise a radio-frequency powerdelivery apparatus to deliver radio-frequency power from aradio-frequency power source to the electro surgical device. Theradio-frequency power source may comprise a radiofrequency generatorlocated in the electro surgical unit.

The fluid delivery apparatus may further comprise a pump, moreparticularly a peristaltic pump and even more particularly a rotaryperistaltic pump. The fluid source may comprise a container containing afluid, such as a bag containing a liquid. More particularly, the fluidsource may comprise an LV. bag containing normal (physiologic or 0.9%)saline solution.

The source equipment may comprise a releasable engagement mechanism toengage and disengage with the cartridge member, as well as a releasablepositioning mechanism to position the cartridge member.

The power delivery apparatus and/or the fluid delivery apparatus may becapable of being in a use position or a non-use position. The powerdelivery apparatus and/or the fluid delivery apparatus may be movable,such as by mechanical movement, to engage with the cartridge member ordisengage from the cartridge member. The power delivery apparatus and/orfluid delivery apparatus may be movable by operation of an actuator(e.g. motor) or manually (e.g. by hand). The power delivery apparatusand fluid delivery apparatus may be simultaneously and/or jointlymoveable.

In another embodiment, the invention provides a cartridge assembly tocouple a device to treat tissue with source equipment, with thecartridge assembly comprising a cartridge member to be placed in acartridge receptacle of the source equipment, and the cartridge memberto operate with a power delivery apparatus of the source equipment and afluid delivery apparatus of the source equipment.

The source equipment may comprise an electrosurgical unit and the tissuetreatment device may further comprise an electrosurgical device.

The cartridge member may receive a radio-frequency power output from theelectro surgical unit, which may comprise bipolar radio-frequency poweror monopolar radio-frequency power. The cartridge member may beelectrically coupled to one or more electrodes of the electro surgicaldevice to provide the radio-frequency power output to the one or moreelectrodes.

The cartridge member may receive a control signal from theelectrosurgical unit. The control signal may comprise a signal tocontrol a radio-frequency power output of the electro surgical unit. Thecartridge member may be electrically coupled to a radiofrequency poweractivation switch of the electrosurgical device to provide the signal tothe radio-frequency power activation switch.

The cartridge member may include electrosurgical device information, andmay provide the electro surgical device information to theelectrosurgical unit, with the electrosurgical device information in aformat which may be readable by the electro surgical unit. The electrosurgical device information may be stored on a storage media.

The electro surgical device information may provide at least oneoperating parameter for a use of the electro surgical device. Theelectro surgical device information may provide at least one of aradio-frequency power level setting and a fluid flow level setting for ause of the electro surgical device. The electronic device informationmay also provide a default setting for a use of the electrosurgicaldevice, a time interval for a use of the electro surgical device or atleast one identifier unique to the electrosurgical device.

The cartridge member may provide an electrical contact which may belocated on a printed circuit board. The electrical contact may becontacted by a pogo (spring loaded) pin of the electro surgical unit.

The cartridge member may provide a storage media. The storage media maycomprise an electronic memory, which may further comprise a programmableread only memory.

The cartridge member may provide a fluid delivery passage to operatewith the fluid delivery apparatus of the electro surgical unit. A lengthof the fluid delivery passage may be defined by a segment of tubing,which may be compressed by an operation of the fluid delivery apparatus.The cartridge member may provide a cartridge body, and a length of thefluid delivery passage may be defined by the cartridge body.

The cartridge member may provide a valve, with the valve in fluidcommunication with a fluid delivery passage. The valve may at leastpartially close the fluid delivery passage when the fluid deliveryapparatus is inactive. The valve may comprise a check valve and moreprecisely a diaphragm check valve.

In another embodiment, the invention provides a method of providing anelectrosurgical system, with the method comprising:

providing an electro surgical unit having a power delivery apparatus anda fluid delivery apparatus, wherein the power delivery apparatus and thefluid delivery apparatus are arranged to operate with a cartridge memberto be placed in a cartridge receptacle of the electrosurgical unit;providing the cartridge member; placing the cartridge member in thecartridge receptacle of the electro surgical unit; engaging thecartridge member with the power delivery apparatus of the electrosurgical unit; and engaging the cartridge member with the fluid deliveryapparatus of the electro surgical unit.

Engaging the cartridge member with the power delivery apparatus of theelectro surgical unit may comprise contacting an electrical contact ofthe cartridge member with an electrical contact of the power deliveryapparatus.

Engaging the cartridge member with the fluid delivery apparatus of theelectro surgical unit may comprise compressing a fluid delivery tubingsegment of the cartridge member with a compression element of the fluiddelivery apparatus.

Engaging the cartridge member with the power delivery apparatus of theelectro surgical unit may comprise moving the power delivery apparatusfrom a non-use position to a use position; and engaging the cartridgemember with the fluid delivery apparatus of the electro surgical unitmay comprise moving the fluid delivery apparatus from a non-use positionto a use position. The power delivery apparatus and fluid deliveryapparatus may be moved simultaneously and/or jointly.

In another embodiment, the invention provides an electrosurgical devicewhich comprises a first electrode spaced alongside a second electrode,with each electrode comprising a blade shaped member. Each blade shapedmember has opposing sides bounded by edges, with the edges comprising amedial edge and a lateral edge. At least one fluid outlet is adjacenteach blade shaped member and each fluid outlet in fluid communicationwith a fluid passage.

Each blade shaped member may have the same size and shape and comprise asheet metal and/or a stamped metal strip. Each blade member may have alength in a range of and any increment between 6 mm to 15 mm, a width ina range of and any increment between 2 mm to 3 mm, and a thickness in arange of and any increment between 0.25 mm to 0.75 mm.

A distal end of each blade shaped member may be rounded from the medialedge to the lateral edge of the blade shaped member, and the roundeddistal end of each blade shaped member may be defined by a radius.

A distal portion of each blade shaped member may be at an obtuse anglerelative to a proximal portion of the blade shaped member. Each obtuseangle may have a vertex extending across a width of each blade shapedmember, and be in a range of and any increment between 91 degrees to 179degrees.

A distal portion of each blade shaped member may include a protrusion onat least one side of the blade shaped member. Each protrusion maycomprise a convex curvature on one side of the blade shaped member.

A distal portion of each blade shaped member may include a protrusion onat least one side of the blade shaped member. Each protrusion maycomprise a convex curvature on one side of the blade shaped member.

A distal portion of each blade shaped member may include a recess on atleast one side of the blade shaped member. Each recess may comprise aconcave curvature on one side of the blade shaped member.

The first electrode may be distal to a distal end of a firstelectrically conductive tube and the second electrode may be distal to adistal end of a second electrically conductive tube. The at least onefluid outlet adjacent the first blade shaped member may be located at adistal end of the first electrically conductive tube and the at leastone fluid outlet adjacent the second blade shaped member may be locatedat a distal end of the second electrically conductive tube.

The blade members may be coplanar. At least a portion of one of theopposing sides of the first blade member may be coplanar and/or parallelwith at least a portion of one of the opposing sides of the second blademember. At least a portion of each opposing side of the first blademember may be coplanar and/or parallel with a corresponding opposingside of the second blade member.

The first and second electrodes may be configured as bipolar electrodes,and at least one of the electrodes may be configured as a monopolarelectrode.

The first and second electrodes may be configured to treat tissue bymoving along a tissue surface in a presence of a bipolar power outputand a fluid provided simultaneously from the fluid outlets.

In another embodiment, the invention provides an electrosurgical device,comprising a first electrode and a second electrode; a switch toactivate and deactivate bipolar power to the first and second electrodesfrom a radio-frequency generator to be coupled to the device, the switchcomprising a double pole, single throw switch, and a switch to activateand deactivate monopolar power to the first electrode from theradiofrequency generator to be coupled to the device, the switchcomprising a single pole, single throw switch.

The double pole, single throw switch may form a control circuit with theradio-frequency generator to be coupled to the device, with the circuitto control activation of the bipolar power from the radio-frequencygenerator when the double pole, single throw switch is in a closedposition, and control deactivation of the bipolar power from theradio-frequency generator when the double pole, single throw switch isin an open position.

The double pole, single throw switch may be in series between the secondelectrode and a bipolar power output of the radio-frequency generator tobe coupled to the device.

The double pole, single throw switch may connect the second electrodewith a bipolar power output of the radio-frequency generator in a closedposition and disconnect the second electrode with the bipolar poweroutput of the radio-frequency generator in an open position.

The single pole, single throw switch may form a control circuit with theradio-frequency generator to be coupled to the device, with the circuitto control activation of the monopolar power from the radio-frequencygenerator when the single pole, single throw switch is in a closedposition, and control deactivation of the monopolar power from theradio-frequency generator when the single pole, single throw switch isin an open position.

The switch to activate and deactivate bipolar power and the switch toactivate and deactivate monopolar power may be both located on ahand-piece of the device.

In another embodiment, the invention provides an electrosurgical devicecomprising a first electrode and a second electrode, a switch toactivate and deactivate monopolar power to the first electrode of thedevice from a radio-frequency generator to be coupled to the device, anda switch to inhibit capacitive coupling of the second electrode to themonopolar power.

The switch to activate and deactivate monopolar power to the firstelectrode of the device from a radio-frequency generator to be coupledto the device may comprise a single pole, single throw switch.

The switch to activate and deactivate monopolar power to the firstelectrode of the device from a radio-frequency generator to be coupledto the device may form a control circuit with the radio-frequencygenerator to be coupled to the device, with the circuit to controlactivation of the monopolar power from the radio-frequency generatorwhen the switch is in a closed position, and control deactivation of themonopolar power from the radio-frequency generator when the switch is inan open position.

The switch to inhibit capacitive coupling of the second electrode to themonopolar power

The switch to inhibit capacitive coupling of the second electrode to themonopolar power may form a control circuit with the radio-frequencygenerator to be coupled to the device, with the circuit to controlactivation of bipolar power from the radio-frequency generator when theswitch is in a closed position, and control deactivation of the bipolarpower from the radio-frequency generator when the switch is in an openposition.

The switch to inhibit capacitive coupling of the second electrode to themonopolar power may be in series between the second electrode and abipolar power output of the radio-frequency generator to be coupled tothe device.

The switch to inhibit capacitive coupling of the second electrode to themonopolar power may connect the second electrode with a bipolar poweroutput of the radio-frequency generator in a closed position anddisconnect the second electrode with the bipolar power output of theradio-frequency generator in an open position.

The switch to activate and deactivate monopolar power and the switch toinhibit capacitive coupling of the second electrode to the monopolarpower may be both located on a hand-piece of the device.

In another embodiment, the invention provides an electro surgical devicecomprising a first electrode and a second electrode and a switch havinga first position to activate monopolar power to the first electrode ofthe device from a radio-frequency generator to be coupled to the deviceand to inhibit capacitive coupling of the second electrode to themonopolar power.

The switch may have a second position to deactivate the monopolar powerto the first electrode of the device from a radio-frequency generator tobe coupled to the device and to connect the second electrode with abipolar power output of the radio-frequency generator.

In another embodiment, the invention provides a first electrode and asecond electrode, each electrode to receive radio frequency power fromfirst and second wire conductors, respectively, and a switch having afirst position to activate monopolar power to the first electrode of thedevice from a radio-frequency generator to be coupled to the device andto disconnect the second electrode from the second conductor.

The switch may have a second position to deactivate the monopolar powerto the first electrode of the device from a radio-frequency generator tobe coupled to the device and to connect the second electrode to thesecond conductor.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of an electrosurgical device with acartridge assembly having a cartridge member to connect a hand-piece toan electrosurgical unit according to one embodiment of the invention;

FIG. 2 is a top view of the cartridge member;

FIG. 3 is a bottom view of the cartridge member;

FIG. 4 is a perspective view of the cartridge assembly showing the innercomponents of the cartridge member;

FIG. 5 is a plan view of the cartridge assembly showing the innercomponents of the cartridge member;

FIG. 6 is a plan view showing certain fluid passages of the electrosurgical device;

FIG. 7 is a diagram of the various electrical connections of a printedcircuit board assembly provided with the cartridge member;

FIG. 8 is a top plan view of the printed circuit board assembly;

FIG. 9 is a bottom plan view of the printed circuit board assembly;

FIG. 10 is a top view of the upper (top) layer of the printed circuitboard assembly;

FIG. 11 is a top view of the lower (bottom) layer of the printed circuitboard assembly;

FIG. 12a is a plan view showing certain electrical connections of theelectrosurgical device;

FIG. 12b is a plan view showing alternative electrical connections ofthe electro surgical device;

FIG. 12c is a plan view showing alternative electrical connections ofthe electrosurgical device;

FIG. 13 is a close-up view of the shaft assembly of the device;

FIG. 14 is a close-up cross-sectional view of the electrodes of thedevice of FIG. 1 taken along line 14-14 of FIG. 13;

FIG. 15 is a close-up cross-sectional view of a distal end portion ofthe device of FIG. 1 taken perpendicular to line 14-14 of FIG. 13;

FIG. 16a is a perspective view of an electro surgical device accordingto another embodiment of the invention;

FIG. 16b is a close-up perspective view of a distal portion of thedevice of FIG. 16 a;

FIG. 16c is a close-up plan view of a distal portion of the device ofFIG. 16 a;

FIG. 16d is a close-up cross sectional view of the device of FIG. 16ataken perpendicular to line 16 d-16 d of FIG. 16 c;

FIG. 16e is a close-up plan view of an electrode of the device of FIG.16 a;

FIG. 16f is a close-up cross sectional view of the electrode of FIG. 16etaken perpendicular to line 16 f-16 f of FIG. 16 e;

FIG. 16g is another close-up perspective view of the distal portion ofthe device of FIG. 16 a;

FIG. 16h is a close of perspective view of an alternative embodiment ofthe electrode of FIG. 16 a;

FIG. 16i is a close of perspective view of an alternative embodiment ofthe electrode of FIG. 16 a;

FIG. 16j is a close of perspective view of an alternative embodiment ofthe electrode of FIG. 16 a;

FIG. 16k is a close of perspective view of an alternative embodiment ofthe electrode of FIG. 16 a;

FIG. 16l is a close of perspective view of a distal portion of analternative embodiment of the device of FIG. 16 a;

FIG. 17a is a perspective view of an electrosurgical unit according toone embodiment of the invention;

FIG. 17b is a perspective view of the electro surgical unit with thecartridge member of the cartridge assembly installed;

FIG. 18 is a perspective view of the electro surgical unit;

FIG. 19 is a front perspective view of the electro surgical unit'sdocking assembly with a movable docking mechanism in the up (non-use)position prior to the docking mechanism engaging with the cartridgemember;

FIG. 20 is a front view of the docking assembly with the dockingmechanism in the up position;

FIG. 21 is a right side view of the docking assembly with the dockingmechanism in the up position;

FIG. 22 is a left side view of the docking assembly with the dockingmechanism in the up position;

FIG. 23 is a rear view of the docking assembly with the dockingmechanism in the up position;

FIG. 24 is a top view of the docking assembly with the docking mechanismin the up position;

FIG. 25 is a rear perspective view of the docking assembly with thedocking mechanism in the up position;

FIG. 26 is a rear perspective view of the docking assembly with thedocking mechanism in the down (use) position;

FIG. 27 is a rear perspective view of a locking mechanism with thedocking mechanism in the up position;

FIG. 28 is rear perspective view of the locking mechanism of with thedocking mechanism in the down position;

FIG. 29 is an exploded view of the cartridge member, upper receptacleenclosure, lower receptacle enclosure and a fluid delivery apparatus;

FIG. 30 is a cross sectional view taken through cartridge member, upperreceptacle enclosure, lower receptacle enclosure and a fluid deliveryapparatus at line 3030 of FIG. 24;

FIG. 31 is a perspective view of the upper receptacle enclosure with aradio-frequency power delivery apparatus;

FIG. 32 is a side view of the upper receptacle enclosure with theradio-frequency power delivery apparatus;

FIG. 33 is a bottom view of the upper receptacle enclosure with aradio-frequency power delivery apparatus;

FIG. 34 is a perspective view of an electrical contact assembly for theradio-frequency power delivery apparatus comprising an electricalinsulator/carrier and electrical contacts;

FIG. 35 is a cross sectional perspective view of the electrical contactassembly of FIG. 34;

FIG. 36 is a cross sectional view of the electrical contact assembly andcartridge member;

FIG. 37 is a front view of one embodiment of a system of the presentinvention having electro surgical unit in combination with a fluidsource and handheld electro surgical device;

FIG. 38 is a display screen for the electro surgical unit requestinginsertion of the cartridge member;

FIG. 39 is a display screen for the electro surgical unit requestingpriming of the electrosurgical device with fluid;

FIG. 40 is a display screen for the electrosurgical unit showing theelectrosurgical unit and system is ready for operation;

FIG. 41 is a display screen for the electro surgical unit showingradio-frequency power is being provided from the unit;

FIG. 42 is an exemplary graph showing a relationship of fluid flow rateQ in units of cubic centimetres per minute (cc/min) on the Y-axis, andthe RF power setting P.sub.s in units of watts on the X-axis;

FIG. 43 is an exemplary graph of the bipolar RF power output versusimpedance for the electrosurgical unit;

FIG. 44 is an exemplary graph of the bipolar RF power output versusimpedance for the electrosurgical unit;

FIG. 45 is a close-up view of a distal end portion of the device of FIG.1 with an exemplary fluid coupling to a tissue surface of tissue;

FIG. 46 is a perspective view of the device of FIG. 1 cutting tissue;and

FIG. 47 is a close-up view of a distal end portion of the device of FIG.16a with an exemplary fluid coupling to a tissue surface of tissue.

DETAILED DESCRIPTION OF THE INVENTION

Throughout the description, like reference numerals and letters indicatecorresponding structure as may also be shown in the figures. Also, anyparticular feature(s) of a particular embodiment may be equally appliedto any other embodiment(s) of this specification as suitable. In otherwords, features between the various embodiments described herein areinterchangeable as suitable, and not exclusive. From the specification,it should be clear that any use of the terms “distal” and “proximal” aremade in reference from the user of the device, and not the patient.

The inventions disclosed herein provide devices, systems and methods fortreating tissue at a tissue treatment site during an electrosurgicalprocedure. Among other features, the inventions disclosed herein areparticularly useful for procedures where it may be desirable to cuttissue, as well as shrink, coagulate and seal tissue against blood andother fluid loss, for example, by shrinking lumens of blood vessels(e.g., arteries, veins).

The invention will now be discussed with reference to the figures, withFIG. 1 showing an exemplary handheld electrosurgical device 10 accordingto one embodiment of the present invention, which may be used inconjunction with a system of the present invention. Accordingly, itshould be understood that the structure of device 10 is not intended tobe limiting as to the scope of devices which can be used with the systemof the invention.

As shown in FIG. 1, exemplary device 10 comprises an elongatedhand-piece 12 having a handle 14 provided by mating handle portions 14a, 14 b. Hand-piece 12 may be slender to enable a user of device 10 tohold and manipulate device 10 between the thumb and index finger like awriting instrument such as a pen. Hand-piece 12 may comprise asterilizable, rigid, electrically insulative material, such as a plasticmaterial. Exemplary plastic materials may comprise polycarbonate (PC)and acrylonitrile-butadiene-styrene (ABS).

Device 10 may be coupled to an electro surgical unit 300 (shown in FIG.17a ) by a cartridge assembly 16 comprising cartridge member 18. Asshown in FIGS. 2 and 3, cartridge member 18 comprises a substantiallyplanar, elongated, rectangular cartridge body 20 comprising matingcartridge body portions 20 a, 20 b. To facilitate proper installation ofcartridge member 18 with electro surgical device 300, cartridge body 20a may include a directional indicator 30 to show the direction in whichcartridge member 18 is to be installed in electrosurgical unit 300, aswell as which side of the cartridge member 18 is the top surface.Furthermore, cartridge body 20 a includes a protruding element 28, shownin the form of an elongated rib, to physically prevent installation ofthe cartridge assembly 16 upside down. Cartridge body 20 may be made ofa sterilizable, rigid, electrically insulative material, such as aplastic material. Exemplary plastic materials may comprise polycarbonate(PC) and acrylonitrile-butadiene-styrene (ABS).

Referring briefly to FIG. 37, when device 10 is connected to othercomponents as part of a system, fluid 502 from a fluid source 500, suchas a bag of saline solution, may be communicated through an enclosedfluid passage provided by various structures. Fluid 502 flows from thefluid source 500 into cartridge member 18 of cartridge assembly 16through lumen 44 of flexible fluid delivery tubing segment 46. At oneend, fluid delivery tubing segment 46 preferably couples to fluid source500 through a drip chamber 48 after the fluid source 500 may bepenetrated with a spike 50 located at the end of the drip chamber 48 ina known manner. In other embodiments, drip chamber 48 may be eliminatedand tubing segment 46 may be attached directly to a spike 50. Fluiddelivery tubing segment 46 may be made of a plastic material, such asflexible polyvinyl chloride (PVC) or other flexible material such as anelastomer.

Referring now to FIGS. 4 and 5, at its opposite end, fluid deliverytubing segment 46 may be coupled and tightly fastened with a fluid tightconnection to cartridge body 20 b of cartridge member 18 via a femaleconnector portion 60. More particularly, fluid delivery tubing segment46 may be coupled to cartridge body 20 b via a distal end portion of thetubing segment 46 extending into a cylindrical cavity 62 formed incartridge body 20 b to provide a cylindrical receptacle. The outersurface of fluid delivery tubing segment 46 may be configured to mateagainst and form a press (interference) fit seal with correspondinginner surfaces of connector portion 60 to provide a fluid tight sealthere between. An adhesive or solvent bonding may be used there betweento further strengthen the seal, or in lieu of the press fit.

Continuing with FIG. 5, from lumen 44 of fluid delivery tubing segment46, the fluid passage extends through a through hole 64 provided at thebase of cavity 62 and may be next provided and defined by an elongatedenclosed channel 68 formed by overlying portions of cartridge bodies 20a, 20 b. More particularly, channel 68 may be formed by mating a channelportion 68 a of cartridge body 20 a with a channel portion 68 b ofcartridge body 20 b and forming a continuous hermetic seal therebetween, particularly by vibration, ultrasonic or other plastic weldingmethod.

From channel 68, the fluid passage thereafter extends through a throughhole 72 formed in male connector portion 74, into lumen 76 of fluiddelivery tubing segment 78 and thereafter through hole 80 formed in maleconnector portion 82. As shown in FIG. 5, fluid delivery tubing segment78 may be coupled and tightly fastened with a fluid tight connection tocartridge body 20 b of cartridge member 18 via male connector portions74 and 82 provided by two spaced, parallel, fixed supports 84 and 86 atthe opposite ends thereof. More particularly, fluid delivery tubingsegment 78 may be coupled to cartridge body 20 b via male connectorportions 74 and 82 which extend into the lumen 76 of delivery tubingsegment 78. The inner surface of lumen 76 of fluid delivery tubingsegment 78 may be configured to mate against and form a press(interference) fit seal with corresponding outer surfaces of connectorportions 74 and 82 to provide a fluid tight seal there between. Anadhesive or solvent bonding may be used there between to furtherstrengthen the seal, or in lieu of the press fit. Similar to fluiddelivery tubing segment 46, fluid delivery tubing segment 78 may be madeof a plastic material, such as flexible polyvinyl chloride (PVC) orother flexible material such as an elastomer.

It may be possible to replace fluid delivery tubing segment 78 toIncrease or decrease the fluid flow output of fluid delivery apparatus420 (discussed in greater detail below) by changing the size (diameter)of lumen 76 of delivery tubing segment 78. Furthermore, fluid deliverytubing segment 78 may require a thicker cross-section and durabilitythan the other fluid delivery tubing segments, such as fluid deliverytubing segment 46. For example, in a particular embodiment discussed ingreater detail below, fluid delivery tubing segment 78 may be configuredto be compressed by a fluid delivery apparatus 422 contained withinelectrosurgical unit 300, to force fluid 502 through the lumen 76thereof in a known manner. In such instance, the thicker portion of thefluid delivery tubing for device 10 may be limited to fluid deliverytubing segment 78.

Continuing with FIG. 5, from through hole 80 of connector portion 82,the fluid passage extends into a cylindrical chamber 90 of a one-way(check) diaphragm valve 38 (FIG. 1) provided and defined chamberportions 90 a and 90 b which are separated by a flat disc shaped plasticmembrane 92. With valve 38, fluid 502 only may flow in one direction. Inuse, when valve 38 is open, membrane 92 may be positioned towards theend of chamber portion 90 a and fluid may be allowed to pass throughchamber 90 and into through hole 98 to exit chamber 90. In order toinhibit back flow of fluid 502, when valve 38 is closed, membrane 92 maybe positioned on seat 96 in a cavity of cartridge body 20 b, whichcloses the fluid passage and fluid communication between the exit portprovided by through hole 98 and the inlet port provided by through hole80. Furthermore, membrane 92 inhibits fluid 502 from flowing throughvalve 38 if the fluid pressure is less than about 3.5 psi. In thismanner, fluid 502 may not flow through valve 38 to handpiece 12 in theevent fluid 502 is introduced to the fluid passage before cassettemember 18 may be installed in electrosurgical unit 300, but rather willonly open to permit flow there through when a pressure of greater than3.5 is provided by fluid delivery apparatus 420 after cartridge member18 has been installed in electro surgical unit 300.

From through hole 98, the fluid passage extends into lumen 104 of fluiddelivery tubing segment 106. Similar to fluid delivery tubing segment46, tubing segment 106 may be coupled and tightly fastened with a fluidtight connection to cartridge body 20 a of cartridge member 18 via afemale connector portion 110. More particularly, fluid delivery tubingsegment 106 may be coupled to cartridge body 20 a via a distal endportion of the tubing segment 106 extending into a cylindrical cavity112 formed by cartridge body 20 a to provide a cylindrical receptacle.The outer surface of fluid delivery tubing segment 106 may be configuredto mate against and form a press (interference) fit seal withcorresponding inner surfaces of connector portion 110 to provide a fluidtight seal there between. An adhesive or solvent bonding may be usedthere between to further strengthen the seal, or in lieu of the pressfit. As shown in FIG. 5, tubing segment 106 may be molded and formedunitary with cord 40, such as by plastic co-extrusion, to provide asingle cable 42.

Referring to FIG. 6, fluid delivery tubing segment 106 enters theproximal end of hand-piece 12 of electro surgical device 10. Withinhand-piece 12 of device 10, fluid delivery tubing segment 106 may beconnected to the inlet branch of a Y-splitter 118, which thereafterprovides two outlet branches which are connected to the proximal ends offluid delivery tubing segments 120 a, 120 b. The distal ends of deliverytubing segments 120 a, 120 b are thereafter connected to the proximalends of shafts 124 a, 124 b. To connect fluid delivery tubing segments120 a, 120 b to shafts 124 a, 124 b, the lumens 122 a, 122 b of thefluid delivery tubing segments 120 a, 120 b are preferably interferencefit over the outside diameter of shafts 124 a, 124 b to provide aninterference fit seal there between. An adhesive or solvent bonding maybe used there between to further strengthen the seal, or in lieu of thepress fit. Fluid 502 may then flow through the lumens 126 a, 126 b ofshafts 124 a, 124 b and thereafter exit from device 10 as discussed ingreater detail below.

Additionally, device 10 may include an aspiration/suction tubing segmentto remove fluid 502 from a tissue treatment site. The suction tubingsegment may pass through cartridge member 18 and thereafter be connectedto a vacuum source.

In addition to operating in conjunction with a fluid delivery apparatus422 within electrosurgical unit 300, as discussed in greater detailbelow, cartridge assembly 16 also operates in conjunction with aradio-frequency power delivery apparatus 440 and other electricalcomponents and circuits within electrosurgical unit 300.

As shown in FIGS. 1 and 2, as well as FIGS. 4 and 5, cartridge member 18includes a two layer printed circuit board 24, one side of which may beexposed through an aperture 32 in cartridge body 20 a of cartridgemember 18 to provide an electrical communication with electro surgicalunit 300. Printed circuit board 24 may comprise a 0.05-0.07 inch thickbase insulator with top and bottom conductive layers deposited thereon.The exposed conductive layers may more particularly comprise 2-6 micronsof gold over 100-300 microns of electroless nickel over copper. Detaileddrawings of printed circuit board 24 may be found in FIGS. 7-11.

As shown in FIGS. 7-11, printed circuit board 24 includes a plurality ofelectrical contacts thereon, which may comprise electrical contact padsto electrically couple with corresponding electrical contacts of electrosurgical unit 300. Certain of these electrical contacts and theirassociated function will now be discussed.

Bipolar radio-frequency power from electrosurgical unit 300 may beprovided from outputs BP+ and BP− thereof. As shown in FIG. 7,electrical contacts J1OIJ27 receive power from bipolar power output BP+which may then communicated along an electrically conductive pathway toelectrical contacts J25/J28. Electrical contacts J11/J16 receive powerfrom bipolar power output BP-which may then communicated along anelectrically conductive pathway to electrical contacts J26/J29.Electrical contacts J10/J27 and J11/J16 are shown in FIG. 8, whileelectrical contacts J25/J28 and J26IJ29 are shown in FIG. 9.

As best shown in FIG. 5, electrical contacts J28 and J29 are coupled tothe proximal end of insulated wire conductors 130 a and 130 b,respectively, of electrical cord 40. As shown in FIG. 12, the distal endof insulated wire conductors 130 a, 130 b ultimately couple with thebipolar electrodes 180 a, 180 b of device 10 as discussed in greaterdetail below.

Additionally, electro surgical unit 300 may be operated in a monopolarmode with monopolar power provided through power output BP+, in whichcase power output BP− is no longer utilized. Rather, as shown in FIG.12, an additional cord 132 is utilized to connect a ground paddispersive electrode 134, which is located on the patient, to theelectro surgical unit 300 using wire conductor 136 and plug 138 at theend thereof which connects to the ground pad receptacle 308 (as shown inFIGS. 16 and 17).

During monopolar operation, an electrode of device 10 is used inconjunction with ground pad dispersive electrode 134 which is placed onthe patient (also known as a patient return electrode or neutralelectrode), typically on the back or other suitable anatomical location.An electrical circuit is formed between the electrode of device 10 andground pad dispersive electrode 134 with electrical current flowing fromthe device electrode through the patient to ground pad dispersiveelectrode 134 in a manner known in the art.

During bipolar operation, the ground pad electrode 134 located on thepatient is not required, and a second electrode providing an electricalpole is provided as part of device 10. An alternating current electricalcircuit is then created between the first and second electrical poles ofthe device. Consequently, alternating current no longer flows throughthe patient's body to the ground pad electrode 134, but rather through alocalized portion of tissue between the poles of the bipolar electrodes.Monopolar and bipolar power may be provided from electro surgical unit300 in a manner known in the art.

Returning to FIG. 7, a control signal from electrosurgical unit 300 maybe provided to electrical contact J14, which is configured to receive acontrol signal from electrosurgical unit 300 as part of a controlcircuit to control bipolar power output. The control signal may thencommunicated along an electrically conductive pathway to electricalcontact J23. As shown in FIG. 5, electrical contact J23 may be coupledto the proximal end of insulated wire conductor 142 of electrical cord40. As shown in FIG. 12, the distal end of insulated wire conductor 142may be coupled to a radio-frequency power hand-switch activationassembly 146 within hand-piece 12. Hand-switch assembly 146 may comprisepush button 148 which overlies a single pole, single throw, domed switch150 on a platform comprising a printed circuit board, with theconstruction and wiring of the hand-switch assembly 146 known in theart. Upon depression of push button 148, the domed switch 150 beneathpush button 148 forms a closed circuit which enables the control signal,here comprising a relatively low voltage direct current, to return andbe sensed by electro surgical unit 300, generally via wire conductor142, which then accordingly provides bipolar power. When the button 148is released, the control circuit opens and the electro surgical unit 300no longer receives the control signal to activate radio-frequency power.Consequently, the electro surgical unit 300 then deactivates the bipolarradio-frequency power output.

A control signal from electro surgical unit 300 may be provided toelectrical contact J15, which is configured to receive a control signalfrom electrosurgical unit 300 as part of a control circuit to controlmonopolar power output. The control signal may then communicated alongan electrically conductive pathway to electrical contact J24. While notshown in FIG. 5, electrical contact J24 may be coupled to the proximalend of insulated wire conductor 144 of electrical cord 40. As shown inFIG. 12, the distal end of insulated wire conductor 144 may be coupledto a radio-frequency power hand-switch activation assembly 152 withinhand-piece 12. Hand-switch assembly 152 may comprise push button 154which overlies a single pole, single throw, domed switch 156, which maycomprise beryllium copper, on a platform comprising a printed circuitboard, with the construction and wiring of the hand-switch assembly 152known in the art. Upon depression of push button 154, the domed switch156 beneath push button 154 forms a closed circuit which enables thecontrol signal, here comprising a relatively low voltage direct current,to return and be sensed by electro surgical unit 300, generally via wireconductor 144, which then accordingly provides monopolar power. When thebutton 154 is released, the control circuit opens and theelectrosurgical unit 300 no longer receives the control signal toactivate radio-frequency power. Consequently, the electrosurgical unit300 then deactivates the monopolar radio-frequency power output.

Exemplary hand switch assemblies may be found in U.S. Publication No.2006/0149225, published Jul. 6, 2006, and U.S. Publication No.2005/0090816, published Apr. 28, 2005, which are assigned to theassignee of the present invention and are hereby incorporated byreference in their entireties to the extent they are consistent.

In certain situations, during monopolar operation of device 10,electrode 180 b may be undesirably energized due to capacitive coupling.In this case, monopolar radio-frequency energy traveling from electrosurgical unit 300 along wire conductor 130 a to electrode 180 a may alsobe transferred to wire conductor 130 b and ultimately to electrode 180 bby capacitive coupling. In a situation where electrical cord 40 isapproximately 10 feet long, and hand-piece 12 is approximately 8 incheslong, radio-frequency monopolar energy may be transferred via capacitivecoupling over a distance of almost 11 feet of device 10.

A solution to capacitive coupling may be to separate the parallel wireconductors 130 a, 130 b along their entire length by a suitabledistance. However, a suitable distance, for the radio-frequency powerlevels being considered, would add significant width or diameter to cord40, and become cumbersome for the user.

Another solution to capacitive coupling may be to introduce anelectrical break or interruption in wire conductor 130 b to effectivelydecrease the length of wire conductor 130 b along which the transfer ofradio-frequency energy to electrode 180 b via capacitive coupling maytake place. To this end, as shown in FIG. 12b , hand-switch assembly 146to activate bipolar power is now in direct electrical communication withwire conductor 130 b and electrode 180 b. Also as shown, switch 150 ofhand-switch assembly 146 as been replaced and hand-switch assembly 146now comprises a double pole, single throw momentary switch 160 which isin series between electrode 180 b and a bipolar power output of electrosurgical unit 300 to be coupled to the device 10.

In the foregoing manner, during monopolar operation of device 10,radio-frequency energy traveling from electrosurgical unit 300 alongwire conductor 130 a to electrode 180 a which may be transferred to wireconductor 130 b by capacitive coupling can no longer travel to electrode180 b given pole 162 of double pole, single throw switch 160 is in theopen position. Thus, any transfer of radio-frequency energy travelingfrom electro surgical unit 300 along wire conductor 130 a to electrode180 a which may be transferred to electrode 180 b by capacitive couplingmay only occur through the portion of the electrical circuit distal topole 162.

Now, with regards to bipolar operation of device 10, as noted abovehand-switch assembly 146 comprises push button 148 which overlies doublepole, single throw switch 160 to activate and deactivate bipolar powerto the first and second electrodes 180 a, 180 b. Upon depression of pushbutton 148, the double pole, single throw switch 160 beneath push button148 simultaneously closes and connects two circuits. First, pole 162,initially in an open circuit position, is now placed in a closed andconnected circuit position such that the bipolar radio-frequency energymay now be provided to electrode 180 b. Additionally, pole 164, alsoinitially in an open circuit position, is now also placed in a closedand connected circuit position to provide a control circuit whichenables the control signal, here comprising a relatively low voltagedirect current, to return and be sensed by electrosurgical unit 300,generally via wire conductor 142, which then accordingly activatesbipolar power. When the button 148 is released, both poles 162, 164return to their initial opened positioned and the control circuitdisconnects and the electro surgical unit 300 no longer receives thecontrol signal and deactivates radio-frequency power. Consequently, theelectrosurgical unit 300 then deactivates the bipolar radio-frequencypower output. Furthermore, the circuit to electrode 180 b also opens,thus inhibiting electrode 180 b from receiving monopolar radio-frequencyenergy during the operation of device 10 in this manner. In thisembodiment, the double pole, single throw switch 160 may be provided bytwo dome switches in overlapping arrangement on opposing sides of acantilevered printed circuit board. In this manner, push button 148 mayact directly upon one of the dome switches, causing the switch to closeto form a closed circuit. Push button 148 may also cause thecantilevered printed circuit board to rotate and move the opposing domeswitch thereon into contact with a mechanical stop which causes thesecond dome also to close to form a closed circuit.

In yet another embodiment, as shown in FIG. 12c , switch 156 ofhand-switch assembly 152 has been replaced with switch 168 and includesbias spring 170, which may be a leaf-spring. As shown, when in a firstposition, switch 168 is in position to deactivate the monopolar power toelectrode 180 a of device 10 from electro surgical unit 300 as thecontrol circuit for monopolar power is now open, and connect electrode180 b with bipolar power output of electro surgical unit 300. In thismanner, when switch 150 is depressed, bipolar power may be provided toelectrodes 180 a, 180 b. After switch 150 is released, switch 168 may bedepressed, against the bias of spring 170, to activate monopolar powerto electrode 180 a, as well as inhibit capacitive coupling of electrode180 b to the monopolar power by disconnecting electrode 180 b fromconductor 130 b. When switch 168 is released monopolar power isdeactivated and spring 170 returns switch 168 to its initial position.

Electrosurgical unit 300 may also be configured to receive a stream ofserial data including certain operating parameters and other informationfrom device 10 concerning the set-up and use of device 10. Inparticular, as shown in FIG. 5, printed circuit board 24 may include anelectronic memory 26 (also shown at U1 in FIG. 7), and more particularlyan electrically erasable programmable read only memory (EEPROM) in whichto store such operating parameters and other information.

For example, memory 26 may include a unique identifier (e.g. modelnumber and serial number) and a fixed time period for use of device 10(e.g. 24 hours) from the time of first radio-frequency activation whichis then stored by electro surgical unit 300 for future reference. Memory26 may include at least one operating parameter such as default settingsfor radio-frequency power level and fluid flow level for device 10, asdiscussed in greater detail below. Memory 26 may include settings for arange of radio-frequency power levels and fluid flow levels for device10, which extend from a minimum radio-frequency power level and minimumfluid flow level to a maximum radio-frequency power level and maximumfluid flow level for device 10. Memory 26 may also include operatingparameters such as one or more relationships which relate fluid flowlevel to the radio-frequency power level over a range of fluid flowlevels and radio-frequency power levels for device 10. As shown in FIG.7, data is received by electrosurgical unit 300 from memory 26 viaelectrical contacts J1 to J4.

Printed circuit board 24 also may include electrical contacts J12 andJ13 which are configured to detect moisture or wetness on printedcircuit board 24. Contacts J12 and J13 are configured to be part of amoisture monitoring circuit provided with a predetermined impedance. Ifthe impedance between the contacts J12 and J13 decreases, such as mayoccur if fluid 502 where to form a bridge between the contacts thuselectrically coupling the contacts, electrosurgical unit 300 may ceaseoperation until the predetermined impedance value is attained.

Cartridge member 18, and in particular printed circuit board 24, alsomay include electrical contacts which are configured to receive powerfor additional features and accessories of device 10 including, forexample a light, such as a light emitting diode (LED) or fiber opticlight, to illuminate a tissue treatment site during a surgicalprocedure. The LED may require a relatively low power, such as amagnitude of 4-5 volts DC (direct current).

Cartridge member 18, and in particular printed circuit board 24 may alsoinclude electrical contacts which are configured to provide connectionand transmit signals to a video recording source to record video, forexample, of a tissue treatment site during a surgical procedure, whichmay be viewed by a video camera, such as a digital or fiber optic videocamera, provided with device 10.

Having discussed the electrical and fluid communication of device 10with electrosurgical unit 300 and fluid source 500, attention will nowbe directed to end effector of device 10 used for the treatment oftissue.

As previously discussed, the distal end of insulated wire conductors 130a, 130 b are coupled to a proximal portion of shafts 124 a, 124 b ofshaft member assembly 128 within hand-piece 12. Now, referring to FIG.13, shaft member assembly 128 comprises two parallel, self-supporting,electrically conductive hollow shafts 124 a, 124 b, which comprise metalsuch as stainless steel tubing. Carried by and connected to the distalends of shafts 124 a, 124 b are two laterally and spatially separated(by empty space) stationary contact elements comprising electrodes 180a, 180 b which may be configured as mirror images in size and shape, andhave a blunt distal end with a surface devoid of edges (to provide auniform current density) to treat tissue. In the present embodimentelectrodes 180 a, 180 b comprise an electrically conductive metal, suchas stainless steel. Other suitable materials may include titanium, gold,silver and platinum.

In certain embodiments, one or both shafts 124 a, 124 b may be made ofelectrically non-conducting material except for the portion at thedistal end that comes in contact with electrodes 180 a, 180 b. In theseembodiment, an insulated wire conductor would extend and be joined tothe electrically conducting portion of shaft 124 a, 124 b. In stillother embodiments, shafts 124 a, 124 b may completely compriseelectrically non-conducting material, in which case an insulated wireconductor would extend and be joined directly to electrodes 180 a, 180b.

As shown in FIG. 13, each electrode 180 a, 180 b comprises an elongatedportion 182 a, 182 b. With respect to length, in the present embodiment,elongated portion 182 a, 182 b has a length in the range of and anyincrement between 2 mm to 6 mm, and more specifically have a length ofin the range of and any increment between 3 mm to 5 mm. With respect tospacing, in the present embodiment the spatial gap separation GS betweenelectrodes 180 a, 180 b in the range of and any increment between 0.1 mmto 4 mm, and more specifically in the range of and any increment between1 mm to 2.5 mm, and more specifically in the range of and any incrementbetween 1.5 mm to 2.3 mm.

As best shown in FIG. 14, opposing concave sides 192 a 1194 a ofelongated portion 182 a, and opposing concave sides 192 b 1194 b ofelongated portion 182 b converge laterally to provide a wedge shapedblade portion 196 a, 196 b which terminates in a lateral cutting edge198 a, 198 b which extends longitudinally along a length of eachelectrode 180 a, 180 b. As shown in FIG. 13, lateral cutting edge 198 a,198 b transitions smoothly onto the distal end of each electrode 180 a,180 b and forms a portion of the distal end of each electrode 180 a, 180b.

Lateral cutting edge 198 a, 198 b may be configured to cut tissueelectro surgically in the presence of monopolar radio frequency energyfrom electro surgical unit 300, without any fluid 502 being providedfrom fluid source 500. However, in other embodiments, lateral cuttingedge 198 a, 198 b may be configured to cut tissue with fluid 502 beingprovided simultaneously from device 10, or be configured to cut tissuemechanically without electro surgical energy. Furthermore, while twocutting edges 198 a, 1988 b are shown, only one of the edges 198 a or198 b may be configured to cut tissue electrosurgically or mechanically.In such instance, the blade portion of one electrode may be eliminatedand the elongated portion may be completely cylindrical.

As shown in FIG. 13, electrodes 180 a, 180 b and elongated portions 182a, 182 b terminate in distal end portion 186 a, 186 b. The distal endportion 186 a, 186 b of electrodes 180 a, 180 b are configured to moveand slide with painting action across a tissue surface in the presenceof bipolar radio frequency energy from electrosurgical unit 300 andfluid 502 from the fluid source 500. As shown, the distal end portion186 a, 186 b of each electrode 180 a, 180 b has a blunt, rounded shapewhich provides a smooth contour surface. More specifically, as shown,distal end portion 186 a, 186 b of each electrode 180 a, 180 b comprisesa spherical portion 190 a, 190 b. In the present embodiment, sphericalportion 190 a, 190 b has a radius in the range of and any incrementbetween 0.5 mm to 1.5 mm, and more specifically in the range of and anyincrement between 0.75 mm to 1.15 mm.

As best shown in FIGS. 14 and 15, within a cylindrical portion 184 a,184 b of each electrode 180 a, 180 b proximal to distal end portion 186a, 186 b, each electrode 180 a, 180 b includes a longitudinally orientedlinear blind bore 200 a, 200 b and counter bore 202 a, 202 b. As shownin FIG. 15, the outside diameter of a distal end portion of each shaft124 a, 124 b may be configured to extend into counter bore 202 a, 202 bof electrodes 180 a, 180 b and fit with the diameter of counter bore 202a, 202 b, with the distal end of each shaft 124 a, 124 b in contact withthe bottom of the counter bore. The electrodes 180 a, 180 b and shafts124 a, 124 b may then be welded together. In alternative embodiments,the outside diameter of shafts 124 a, 124 b may be configured to fitwith the diameter of counter bore 202 a, 202 b to form a press(interference) fit to provide a secure connection. In other alternativeembodiments, electrodes 180 a, 180 b may be assembled to shafts 124 a,124 b by threaded engagement. In still other embodiments, electrodes 180a, 180 b may be detachably assembled to shafts 124 a, 124 b such thatthey may be removed from the shafts 124 a, 124 b, preferably manually byhuman hand.

In addition to blind bore 200 a, 200 b and counterbore 202 a, 202 b, asshown in FIG. 14, electrodes 180 a, 180 b also include a through bores204 a 1206 a and 204 b 1206 b which perpendicularly intersects bore 200a, 200 b and perpendicularly intersect one another to provide outlets208 a 1210 a 1212 a 1214 a and 208 b/210 b/212 b 1214 b for fluid 502.Thus, after fluid 502 flows through the lumens 126 a, 126 b of shafts124 a, 124 b, fluid 502 then flows through into the tubular passageprovided by blind bore 200 a, 200 b and then into the tubular passageprovided by through bores 204 a 1206 a and 204 b/206 b where itthereafter exits device 10 from fluid outlets 208 a 1210 a 1212 a 1214 aand 208 b/210 b 1212 bI214 b, which are all proximal to distal endportion 186 a, 186 b of electrodes 180 a, 180 b. As shown in FIG. 14,fluid outlets 208 a 1212 a and 208 b/212 b are defined by thecylindrical portion 184 a, 184 b of electrodes 180 a, 180 b, while fluidoutlets 210 a 11214 a and 210 b 1214 b are defined by sides of 192 a1194 a and 192 b 1194 b of blade portion 196 a, 196 b and adjacentcutting edge 198 a, 198 b.

As best shown in FIGS. 13 and 15, a portion of the lengths of shafts 124a, 124 b are surrounded by and encapsulated in a common outer member216, which may comprise a flexible plastic material. Outer member 216electrically insulates the exposed length of shafts 124 a, 124 b.

Outer member 216 may be formed by injection molding. During theinjection molding process, a sub-assembly comprising electrodes 180 a,180 b and shafts 124 a, 124 b may be placed in an injection mold priorto the introduction of the plastic material. Thereafter, the mold may beclosed and a thermoplastic may be injected into the unoccupied portionsof the mold cavity to overmold and mold-in place portions of thesub-assembly as shown in FIG. 13. During the injection molding process,retainer clips (not shown) may provide the benefit of retaining shafts124 a, 124 b in position relative to each other to better ensure thatthe shafts 124 a, 124 b are centrally located within the polymermolding.

To be hand shapeable by surgeons and other users of device 10, so thatthe device 10 may be used in a greater multitude of angles andlocations, at least a portion of shafts 124 a, 124 b of device 10 may bemalleable to provide a malleable shaft member assembly 128. Also, inthis manner, a distal portion of shafts 124 a, 124 b may be bendable atan angle relative to the longitudinal axis of the proximal portion ofshafts 124 a, 124 b during manufacturing of device 10 so they may beprovided to users of device 10 at various angles. For example, angle mayrange from 5 degrees to 90 degrees, and more specifically, 15 degrees to45 degrees, and even more specifically 30 degrees. As used herein,malleable means able to be shaped, particularly by bending (without amechanical mechanism, such as a hinge or joint). It should be understoodthat shaft member assembly 128 may independently maintain the shapeassociated with the selected bent shape, and does not require additionalcomponents (e.g., pull wires, etc.) to maintain the selected bent shape.Furthermore, shaft member assembly 128 may maintain the selected, shapesuch that when device 10 is used to treat tissue, and will not overtlydeflect from the selected shape. Furthermore, shaft member assembly 128may be constructed such that a user can readily re-shape the shafts backto a straight state and/or other desired bent configurations.

Outer member 216, in addition to electrically insulating shafts 124 a,124 b from one another, has been found to be particularly useful infacilitating the hand shaping of shafts 124 a, 124 b of shaft memberassembly 128 simultaneously and with a similar contour without crackingand maintaining the tip spacing. In this manner, surgeons and otherusers of device 10 need not bend the shafts 124 a, 124 b individually.

To provide malleability, shafts 124 a, 124 b preferably have an outerwall diameter of about 0.063 inches and an inner wall diameter of about0.032 inches. Shafts 124 a, 124 b also preferably are made from 304stainless steel with a temper from about ½ to ¾ hard, 130,000 to 150,000psi. (pounds per square inch) tensile strength) and an elongation atbreak of about 40%. Shafts 124 a, 124 b with the foregoing propertiesprovide sufficient stiffness as not to be too pliable during normal useof device 10, while at the same time inhibiting the shafts 124 a, 124 bfrom kinking or breaking when shaped for application. When the wallthickness may be too thin, shafts 124 a, 124 b may kink, and when thewall thickness may be too thick, the shafts 124 a, 124 b may be toostirr. Furthermore, a shaft 124 a, 124 b b with a larger diameter mayalso kink more than a shaft of smaller diameter. Shafts 124 a, 124 b mayalso be malleable for a portion of the length or full length dependingon application. For example, the shafts 124 a, 124 b can be made withvariable stiffness along the length and be malleable only for a distalportion thereof. This may be performed by controlled annealing of theshafts 124 a, 124 b only in the area where malleability may be desired.

Another embodiment of device 10 is shown in FIGS. 16a-16g which shows analternative hand-piece 12 a. In comparison to hand-piece 12, theelectrodes 180 a, 180 b shown with hand-piece 12 a are narrower withless mass as to provide a narrower incision when cutting tissue, makingthe device less obtrusive, and also enhancing visibility.

As best shown in FIG. 16b and FIG. 16c , each elongated portion I82 a,I82 b of electrodes I80 a, I80 b still may comprise a blade portion andhave a lateral edge configured and arranged to operate in similarfashion to the previous embodiment. However, unlike the electrodes I80a, I80 b of FIG. 13, the cylindrical portion I84 a, 184 b has beeneliminated. The elongated portion I82 a, I82 b provides a blade shapedmember with an elongated substantially planar body having a lengthsignificantly greater than its width, and a width significantly greaterthan its thickness. Here, for example, the length may be in the range ofand any increment between 6 mm to 15 mm, the width may be in the rangeof and any increment between 2 mm to 3 mm, and the thickness may be inthe range of and any increment between 0.25 mm to 0.75 mm. With respectto spacing, in the present embodiment the spatial gap separation GSbetween the electrodes I80 a, I80 b is the same as for the previousembodiment. As shown, to provide a self-supporting single layerconstruction, each electrode 180 a, 180 b may be formed from planarmetal in the form of a metal strip and, more specifically, sheet metalwhich may be formed by stamping or otherwise formed using a stamping dieor other forming die.

As best shown in FIG. 16d , each elongated portion 182 a, 182 bcomprises opposing sides 220 a/222 a, 220 b/222 b; a medial edge 224 a,224 b and a lateral edge 226 a, 226 b. To better clarify orientation,the thickness T of each elongated portion 182 a, 182 b is shown toseparate sides 220 a, 220 b from sides 222 a, 222 b, while the width Wof each elongated portion I82 a, 182 b is shown to separate the medialedges 224 a, 224 b from the lateral edges 226 a, 226 b.

Lateral edge 226 a, 226 b may further include a bevel on either or bothsides thereof to provide a single or double bevel lateral edge,respectively. As shown, elongated portion I82 a includes a bevel 227 a,229 a on each side 220 a, 222 a, respectively, to provide double beveledge 226 a. Similarly, elongated portion 182 b includes a bevel 227 b,229 b on each side 220 b, 222 b, respectively, to provide double beveledge 226 b.

Lateral edge 226 a, 226 b, as well as distal end 228 a, 228 b may beconfigured to cut tissue electro surgically in the presence of monopolarradio frequency energy from electro surgical unit 300, without any fluid502 being provided from fluid source 500. However, in other embodiments,lateral cutting edge 226 a, 226 b may be configured to cut tissue withfluid 502 being provided simultaneously from device 10, or be configuredto cut tissue mechanically without electrosurgical energy. Furthermore,while two cutting edges 226 a, 226 b are shown, only one of the edges226 a or 226 b may be configured to cut tissue electro surgically ormechanically.

Medial edges 224 a, 224 b are also shown to include a bevel on bothsides thereof to provide a double bevel medial edge. However, unlikedouble bevel lateral edge 226 a, 226 b, double bevel medial edge 224 a,224 b is not intended to be used to cut tissue and the double bevelexists predominately as a result of electrodes 180 a, 180 b beinginterchangeable for ease of manufacturing.

Referring back to FIGS. 16b and 16c , each electrode 180 a, 180 b isshown to have a distal (terminal) end 228 a, 228 b which is rounded,particularly from each medial edge 224 a, 224 b to the lateral edge 226a, 226 b of the elongated portion 182 a, 182 b of each electrode 180 a,180 b. More particularly, each rounded distal end 228 a, 228 b may bedefined by a uniform radius. In this manner, the distal end of thedevice is void of sharp corners which could inadvertently snag, pierceor otherwise damage tissue.

As best shown in FIGS. 16e and 16f , each electrode 180 a, 180 b (onlyelectrode 180 a is shown, electrode 180 b is similar) may furtherinclude a distal portion 230 a, 230 b which is at an obtuse angle Arelative to side 220 a, 220 b and proximal portion 232 a, 232 b, withthe obtuse angle A having a vertex which extends across the width ofeach electrode 180 a, 180 b. In this manner, each electrode 180 a, 180 bmay have the general shape of a ski tip. In certain embodiments, theobtuse angle A may be in a range of and any increment between 91 degreesto 179 degrees and more particularly in a range of and any incrementbetween 120 degrees to 175 degrees and even more particularly in a rangeof and any increment between 145 degrees to 170 degrees (e.g. 165degrees). In this manner, the electrodes 180 a, 180 b are betterconfigured to move across tissue during the treatment thereof asdescribed in greater detail below. In various embodiments, theelectrodes 180 a, 180 b may be malleable (e.g. made from Y4 to % hardstainless steel) to better facilitate bending of electrodes 180 a, 108 bto change the obtuse angle.

As best shown in FIGS. 16f and 16g , the distal portion 230 a, 230 b ofeach electrode 180 a, 180 b may further include a protrusion 234 a, 234b located on side 222 a 222 b, which is opposite the side 220 a, 220 bof the obtuse angle, but on the same side as outlets 240 a, 240 bdescribed in greater below. Stated another way, protrusion 234 a, 234 bis located on side 222 a 222 b of distal portion 230 a, 230 b which isat a reflex angle B relative to proximal portion 232 a, 232 b. Here, thereflex angle B may be in the range of and any increment between 181degrees to 269 degrees, and may be calculated by subtracting the valueof the obtuse angle A from 360 degrees.

As show, each protrusion 234 a, 234 b here comprises a convex curvature,shaped like a circular dimple, which provides a blunt, rounded shapewhich provides a smooth contour surface. In the present embodiment, theconvex curvature has a diameter in the range of and any incrementbetween 0.5 mm to 1.5 mm, and more specifically in the range of and anyincrement between 0.75 mm to 1.15 mm. Protrusion 234 a, 234 b may beformed by stamping or otherwise forming a recess 236 a, 236 b, here aconcave curvature, in distal portion 230 a, 230 b on side 220 a, 220 busing a stamping die or other forming die.

As discussed in greater detail below, protrusions 234 a, 234 b ofelectrodes 180 a, 180 b may be used to move and slide electrodes 180 a,180 b with painting action across a tissue surface in the presence ofbipolar radio frequency energy from electro surgical unit 300 and fluid502 from the fluid source 500, while, at the same time functioning asstandoffs to separate lateral edges 226 a, 226 b from contacting thetissue surface and inhibit edges 226 a, 226 b from cutting the tissuewhen the device 10 is used in this orientation. In this orientation,sides 220 a, 220 b may be referred to as the upper sides relative to thetissue being treated while sides 222 a, 222 b may be referred to thelower sides.

In order to best facilitate use of the hand-piece 12 a in the foregoingmanner, electrodes 180 a, 180 b are shown to be coplanar (i.e. athickness of each electrode 180 a, 180 b is in a common plane). Moreparticularly, at least a portion of at least one of the opposing sides220 a/222 a of electrode 180 a is parallel and coplanar with opposingsides 220 b/222 b of electrode 180 b, respectively. Even moreparticularly, at least a portion of each side 220 a/222 a of electrode180 a is parallel and coplanar with a corresponding side 220 b/222 b ofelectrode 180 b, respectively.

With regards attachment to shafts 124 a, 124 b of shaft member assembly128, electrodes 180 a, 180 b include a semi-circular tab portion 238 a,238 b which may be welded to the side of shafts 124 a, 124 b. As shown,tabs 238 a, 238 b are welded to shafts 124 a, 124 b such that electrodes180 a, 180 b extend distally from shafts 124 a, 124 b and fluid from thelumens 126 a, 126 b is expelled from fluid outlets 240 a, 240 b locatedat the distal end of shafts 124 a, 124 b and adjacent the electrodes 180a, 180 b on the same side as protrusions 234 a, 234 b.

In alternative embodiments, electrodes 180 a, 180 b and shafts 124 a,124 b may be unitary and continuous. In other words, may be formed froma single piece of metal which is uninterrupted. For example, the metalused to provide electrodes 180 a, 180 b, such as planar metal which maybe in the form of a metal strip (such as sheet metal), may include aproximal portion which may be formed into the shape of a tube, as shownin FIG. 16h (only electrode 180 a shown, electrode 180 b similar), suchas by roll forming, and thereafter welded along the longitudinal seam242 a to provide a sealed tube. Alternatively, a distal end portion ofthe metal shafts 124 a, 124 b, such as stainless steel tubes, may beflattened and shaped to provide the form and function of electrodes 180a, 180 b as shown in FIG. 16i (only electrode 180 a shown, electrode 180b similar). In this manner, an opening would also be provided in theside wall of shafts 124 a, 124 b adjacent the flattened portion toprovide fluid outlets 240 a, 240 b.

Also in alternative embodiments, fluid outlets 240 a, 240 b may belocated on the opposite side of protrusions 234 a, 234 b, as shown inFIG. 16j (only electrode 180 a shown, electrode 180 b similar). In thismanner, fluid from fluid outlets 240 a, 240 b may flow distally onsurfaces 220 a, 220 b to recesses 236 a, 236 b. Thereafter, oncerecesses 236 a, 236 b are filled with fluid, the fluid may overflow therecesses 236 a, 236 b and flow out of the recesses to protrusions 234 a,234 b. In yet another alternative embodiment, electrodes 180 a, 180 bmay be positioned relative to the fluid outlets 240 a, 240 b such thatfluid outlets 240 a, 240 b are located on both sides 220 a, 220 b and222 a, 222 b as shown in FIG. 16k (only electrode 180 a shown, electrode180 b similar).

Also in alternative embodiments, fluid outlets 240 a, 240 b may beeliminated and a single fluid outlet 240 may be provided betweenelectrodes 180 a, 180 b as shown in FIG. 16 l.

Having discussed electro surgical device 10 in detail, attention willnow be directed to electrosurgical unit 300 shown starting at FIG. 17a .As shown in FIGS. 17a and 17b , electrosurgical unit 300 includes afront control panel 302. Front control panel 302 includes a power(on/off) switch 304 and touchscreen graphical user interface (GUI) 306.Front panel 302 also includes a ground pad receptacle 308 as well as acartridge receptacle 310 configured to receive cartridge member 18 ofcartridge assembly 16, which is shown installed in FIG. 17 b.

As shown in FIG. 18, electro surgical unit 300 includes an AC powersupply 320, radio-frequency power source/generator 322, controller 338,including a central processing unit (CPU) and memory, and cartridgedocking assembly 340 all interconnected and designed to communicate andfunction as an electro surgical unit which provides radio-frequencypower in a manner known in the art.

As shown in FIG. 19, electrosurgical unit 300 includes a dockingassembly 340 with cartridge member 18 placed between upper receptacleenclosure 348 and lower receptacle enclosure 350. Front, right side,left side, rear and top views of the docking assembly 340 with amoveable docking mechanism 410 in the up (non-use) position prior toengaging with cartridge member 18 are shown in FIGS. 20-24,respectively. Operation of the docking assembly 340 will now bediscussed in greater detail, with FIGS. 20-24 presented as needed.

Referring to FIG. 25, upper receptacle enclosure 348 and lowerreceptacle enclosure 350 have been hidden to better show the operationof docking assembly 340. As shown in FIG. 25, near the end of insertionof cartridge member 18, the distal end 22 of cartridge member 18 firstinteracts with engagement mechanism 342, which is to inhibit thecartridge member 18 from inadvertently sliding out of receptacle 310 andseparating from electrosurgical unit 300, as well as releaseably engagethe cartridge member 18 when sufficient removal force may be applied tothe engagement mechanism 342 to disengaged the cartridge member 18 andretract it from receptacle 310.

As shown, the engagement mechanism 342 comprises a spring loaded ball344 which may enter a detent 34 (shown in FIG. 3) which may be providedas part of the lower cartridge enclosure 350 (not shown). Engagementmechanism 342 acts to hold the cartridge member 18 in a temporary fixeduse position relative to the electrosurgical unit 300. As the cartridgemember 18 is inserted into receptacle 342, the lower surface ofcartridge body 20 b slides over the spring loaded ball 344 with asufficient insertion force to overcome the bias/compression force of thespring 346 and retract the ball 344. As the cartridge member 18thereafter reaches its use position, the ball 344 enters a detent 34formed in cartridge body 20 b (shown in FIG. 3) which, under the forceof compressed spring 346, now acts to hold the cartridge member 18 andelectrosurgical unit 300 at their relative positions. Furthermore, theengagement mechanism 342 provides the user with tactile feedback thatthe cartridge member 18 has been properly received by electro surgicalunit 300. Alternately, after ejection may be selected and a removalforce is applied to cartridge member 18 sufficient to overcome theretention force applied by the spring 346, the spring 346 may again becompressed and the ball 344 removed from the detent 34 to facilitateremoval of the cartridge member 18 from the electrosurgical unit 300.

As the ball 344 enters detent 34, the distal end 22 of cartridge member18 now makes contact with a two position contact switch 354 which, whencartridge member 18 is absent, is in the open position. As cartridgemember 18 is more fully inserted into cartridge receptacle 310 with aninsertion force sufficient to close switch 354, an electrical circuit inthe electrosurgical unit 300 may be closed which provides a signal to acontroller 338 within electro surgical unit 300 that a cartridge member18 has been fully inserted into cartridge receptacle 310. Upon receiptof the signal that a cartridge member 18 has been fully inserted intothe cartridge receptacle 310, electro surgical unit 300 may now energizea solenoid 356.

Referring now to FIG. 25 and FIG. 26, solenoid 356 retracts armature358, which may be coupled to lever 360 by pull bar 362. Consequently,upon retraction of armature 358, lever 360 may be rotated about pivot364 and lever portion 366 rotates downward from its non-use (unengaged)position, as shown in FIG. 25, to its use (engaged) position, as shownin FIG. 26. As lever portion 366 rotates downward, pin 368 enterscylindrical cavity 36 formed in cartridge body 20 a. Pin 368 performsmultiple functions. First, pin 368 provides a locking mechanism toprevent inadvertent removal or dislodging of cartridge member 18 whileelectro surgical unit 300 is ready for operation. Pin 368 also providesa locating/positioning mechanism to further position cartridge member 18relative to electro surgical unit 300 in addition to engagementmechanism 342.

Lever 360 may be pulled downward to its use (engaged) position withsufficient force to overcome the bias/compression force of spring 370,which thereafter returns lever 360 to its non-use position when power isremoved from solenoid 356 and armature 358 is free to extend.

As lever 360 is rotated about pivot 364, lever portion 376, which isopposite lever portion 366, rotates upward about pivot 364. As shown inFIG. 27 and FIG. 28, lever portion 376 includes a catch 378 in the formof a notch into which locking pin 380 with roller 388 enter and are nowcaptured as a result of the rotation of lever 360.

As a result of pin 380 and roller 388 entering catch 378 as shown inFIG. 28, lever 384 (shown in phantom in FIGS. 27 and 28), which rotatesabout pivot 386, may only travel rearward based on the length of catch378. In other words, once pin roller 388 makes contact with the rearwardsurface 382 of catch 378, lever 384 may now be prevented from furtherrearward travel relative to lever 360 due to roller 388 contacting lever384.

Returning to FIG. 26, once lever 360 is in its use position, an opticalsensor then provides a signal to a controller within the electrosurgical unit 300 that lever 360 is in such position. Upon receipt ofthe signal that lever 360 is now in its use position, electrosurgicalunit 300 now activates electric motor 396 which turns shaft 398 via agearbox 400. Shaft 398 provides an axle for cam 402 which, as a resultof the rotation of shaft 398, contacts surface 404 of lever 384.

Upon rotation of cam 402 against surface 404 of lever 384, lever 384 maytravel rearward until roller 388 makes contact with the rearward surface382 of catch 378. As the position of lever 384 may now be fixed againstmoving rearwards by roller 388 fixated on contacting lever 384, surface404 now provides a fixed load bearing surface against cam 402. As aresult, upon further rotation of cam 402 against surface 404, movabledocking mechanism 410 rotates downward and moves radially about pivot412 (shown in FIG. 22) against the bias/tension force of spring 414(shown in FIG. 23) until it reaches its use position as sensed by anoptical sensor. Docking mechanism 410 is now in its use (engaged)position. In other words, ready to deliver radio-frequency power andfluid as designed. After use of electro surgical unit 300 is complete, auser may eject cartridge member 18 from unit 300 by selecting suchcontrol on unit 300, and the reverse of the docking procedure may beperformed.

Should power be removed from solenoid 356 while docking mechanism 410 isin its use position, for instance if unit 300 is unplugged, electrosurgical unit 300 may be configured to return docking mechanism 410upward to its non-use position and allow cartridge member 18 to beremoved. As indicated above, when power is removed from solenoid 356,armature 358 may be free to extend and lever portion 366 of lever 360rotates upward about pivot 364 due to the force of spring 370 to removepin 368 from cylindrical cavity 36 formed in cartridge body 20 a.Simultaneously, lever portion 376 of lever 360 rotates downward aboutpivot 364 to disengage locking pin 380 with roller 388 from catch 378.Upon the disengaging of locking pin 380 and roller 388 from catch 378,lever 384 may now be free to move rearward about pivot 386. The force ofspring 414 then overcomes the force of spring 416 and moves lever 384rearward, releasing cam 402 from acting on surface 404. As cam 402releases from surface 404, docking mechanism 410 is rotated upwardsabout pivot 412 due to the force of spring 414. As docking mechanism 410returns to its non-use position, and cam 402 rotates back to the not inuse position, lever 384 moves forward about pivot 386 due to the forceof spring 416. In this manner, locking pin 380 and roller 388 are nowpositioned to be received by catch 378.

Referring now to FIG. 29, FIG. 29 shows an exploded view of thecartridge member 18, upper receptacle enclosure 348, lower receptacleenclosure 350 and a fluid delivery apparatus 420. Fluid deliveryapparatus 420 comprises a peristaltic pump assembly 422, and morespecifically a rotary peristaltic pump assembly. As shown in FIG. 30,compression elements shown as pinch rollers 424 of pump head 434 rotateabout shaft 426 which may be turned by motor 428. As shown, whenassembly is in its use position, rollers 424 engage and compress pumptubing segment 78 in a known manner against opposing load bearingsurface 430 of semi-circular shoe/base 432 to pump fluid 502 from thefluid source 500 to the hand-held device 10.

Fluid 502 may be conveyed by peristaltic pump assembly 422 by waves ofcontraction placed externally on the delivery tubing segment 78 whichare produced mechanically by rotating pinch rollers 424 which rotate ondrive shaft 426 and intermittently compress the delivery tubing segment78 against support surface 430. Peristaltic pumps are generallypreferred, as the electro-mechanical force mechanism, here rollers 424driven by electric motor 428, does not make contact with the fluid 502,thus reducing the likelihood of inadvertent contamination.

Referring to FIG. 19 and FIG. 31, as docking mechanism 410 rotatesdownwards towards its use position, drive coupling 438 contactsradio-frequency power delivery apparatus 440 and pushes an electricalcontact assembly 442 linearly downwards towards printed circuit board 24of cartridge member 18 against the bias/compression force of spring 444.Conversely, upon docking mechanism 410 rotating upwards towards itsnon-use position, spring 444 raises electrical contact assembly 442 awayfrom printed circuit board 24 and to its non-use position.

In the above manner, both power delivery apparatus 440 and fluiddelivery apparatus 420 move simultaneously to save time as compared toif they were to move sequentially, as well jointly, thus requiring onlyone shared drive mechanism, here comprising motor 396, rather than twoseparate drive mechanisms.

As shown in FIG. 32 and FIG. 33, electrical contact assembly 442 extendsthrough an aperture 452 in upper receptacle enclosure 348. As shown inFIG. 34 and FIG. 35, electrical contact assembly 442 comprises aplurality of electrical contacts 446 which extend through an electricalinsulator/carrier 448.

As shown in FIG. 36, electrical contacts 446 are configured to mate andelectrically communicate with the electrical contacts of printed circuitboard 24, as well as the electric components and circuitry ofelectrosurgical unit 300 in a manner known in the art.

Electrical contacts 446 comprise a plurality of pogo (spring loaded)pins. As the pogo pins 446 make contact with printed circuit board 24,the pins 446 retract under load in a known manner until electricalinsulator/contact carrier 448 may be positioned in contact with printedcircuit board 24 and the pins 446 substantially retract into carrier448. As shown in FIG. 36, an end portion of electrical contact carrier448 may be configured to fit within aperture 32 of cartridge member 18.

Returning to FIG. 32, should electrical contact carrier 448 make contactwith printed circuit board 24, radio-frequency power delivery apparatus440 includes springs 450 which will compress upon reaching a loadsufficient to overcome the bias/compression force of springs 450, withsuch force being lower than the force which may damage printed circuitboard 24. In this manner, printed circuit board 24 may be protected fromdamage upon engagement with electrical contact assembly 442. Apparatus440 also has the function of aligning contact carrier 448 to aperture 32of cartridge member 18. In particular, the springs 450 and pins 454(shown in phantom) are designed to allow the contact carrier 448 tofloat and align to the aperture 32 of cartridge member 18 as carrier 448enters aperture 32, then return the contact carrier 448 to a straightposition when retracted.

Having discussed electrosurgical unit 300 in detail, attention will nowbe directed to a system in which electro surgical device 10 and electrosurgical unit 300 may be arranged and used, with FIG. 37 showing a viewof one embodiment of a system of the present invention having exemplaryelectro surgical unit 300 in combination with a fluid source 500 and ahandheld electro surgical device 10. FIG. 37 shows a movable cart 504having a support member 506 comprising a hollow cylindrical post whichcarries a platform 508 comprising a pedestal table to provide a flat,stable surface for location of the electro surgical unit 300.

As shown, cart 504 further comprises a fluid source carrying pole 510having a height which may be adjusted by sliding the carrying pole 510up and down within the support member 506 and thereafter secured inposition with a set screw. On the top of the fluid source carrying pole510 is a cross support provided with loops at the ends thereof toprovide a hook for carrying fluid source 500.

As shown in FIG. 37, fluid source 500 may comprise a bag of fluid fromwhich the fluid 502 flows through drip chamber 48 after the bag ispenetrated with a spike 50 located at the end of the drip chamber 48. Inother embodiments, drip chamber 48 may be eliminated and tubing segment46 may be attached directly to a spike 50. Thereafter, fluid 502 flowsthrough flexible delivery tubing segment 46, cartridge member 18 anddelivery tubing segment 106 of cable 42 to hand-piece 12 electrosurgical device 10.

In the present embodiment the fluid 502 comprises saline solution, andeven more specifically, normal (physiologic) saline. Although thedescription herein may make reference to saline as the fluid 502, otherelectrically conductive fluids can be used in accordance with theinvention.

While an electrically conductive fluid having an electricallyconductivity similar to normal saline is preferred, as will become moreapparent with further reading of this specification, fluid 502 may alsocomprise an electrically non-conductive fluid. The use of anon-conductive fluid, while not providing all the advantage of anelectrically conductive fluid, still provides certain advantages overthe use of a dry electrode including, for example, reduced occurrence oftissue sticking to the electrodes 180 a, 180 b of device 10 and coolingof the electrodes and/or tissue. Therefore, it is also within the scopeof the invention to include the use of a non-conducting fluid, such as,for example, deionized water.

As indicated above, electrosurgical unit 300 is configured to provideboth monopolar and bipolar power output. However, electro surgical unit300 preferably includes a lock out feature which prevents both monopolarand bipolar output from being activated simultaneously.

When the power switch 304 is turned on electro surgical unit 300, anumber of touch control screens are presented to the user from thegraphical user interface 306 to set up the use of device 10. As shown inFIG. 38, after performing an initial system check, a display 312 ispresented to the user requesting insertion of cartridge member 18. Uponcartridge member 18 being placed in cartridge receptacle 310, controller338 receives a signal of the presence thereof from a sensor. Controller338 then initiates the movement of docking mechanism 410 from itsnon-use (unengaged) position to its use (engaged) position.

Upon reaching its use (engaged) position, controller 338 receivesanother signal to indicate such from another sensor. After receiving thesignal, controller 338 now may access the memory 26 of cartridge member18 for certain information stored thereon concerning device 10.

As indicated above, electro surgical unit 300 may be configured toreceive and read a stream of serial data including certain processparameters and other information from device 10. Controller 338 maydetermine if memory 26 includes a unique identifier such as a serialnumber for device 10. If so, the controller 338 may read and store theserial number to its own memory. Controller 338 may also determine if afixed time period (e.g. 24 hours) for use of device 10 is included inmemory 26. If so, controller 338 may apply the time period to aninternal countdown clock, which may begin counting the time period downafter the first radio-frequency power activation of unit 300 with device10 therein. Thereafter, once the time period has expired, controller 338may be programmed to associate the serial number with an expired device10 and no longer operate device 10. In this manner, use of device 10with cartridge 18 may be limited as intended to a single use disposableto better assure patient safety.

As shown in FIG. 39, after electrosurgical unit 300 senses the insertionof cartridge member 18, a display 314 is presented to the user toconfirm that that fluid source 500 has been spiked, and to initiatepriming of electro surgical device 10 with fluid 502. Priming isdesirable to inhibit radio-frequency power activation without thepresence of fluid 502 in device 10.

After priming is complete, as shown in FIG. 40, display 316 is presentedto the user indicating that the system is now ready for use.Additionally, display 316 presents the user with default radio-frequencypower level settings 328 and 330 numerically in watts, which may bethereafter increased or decreased by touching radio-frequency powerlevel selectors 332 a, 334 a and 332 b, 334 b, respectively. RF poweroutput may be set in 1 watt increments in the range of 1 to 40 watts, 5watt increments in the range of 40 to 100 watts and 10 watt incrementsin the range of 100 to 300 watts. When radio-frequency power isactivated, the system ready portion of the display will change tovisually indicate that radio-frequency power is active as shown in FIG.41.

In addition to display 316 presenting a user with a defaultradio-frequency power level setting, display 316 also presents the userwith a plurality of fluid flow settings 336 a, 336 b and 336 c, whichcorrespond to fluid flow settings of low (represented by one fluiddroplet), medium (represented by two fluid droplets) and high(represented by three fluid droplets), respectively. The appropriatesetting will illuminate when selected to visual indication of such tothe user, with the medium (or intermediate) setting generally being thedefault setting.

Controller 338 of electro surgical unit 300 may also be programmed toobtain and read the default settings for radio-frequency power level andfluid flow level for device 10 which may be stored in memory 26 andthereafter set the unit 300 to these settings and present these defaultsettings on display 316.

Controller 338 of electrosurgical unit 300 may be programmed to obtainand read a maximum power level for use of device 10 which is stored inmemory 26. In this manner, electro surgical unit 300 would not activateits radio-frequency power for device 10 should the user wish to select aradio-frequency power level greater than the maximum power levelallotted.

Controller 338 of electrosurgical unit 300 may also be programmed toobtain and read data from memory 26 which relates a speed of the pumpassembly 422, and therefore the throughput of fluid 502 expelled byfluid delivery apparatus 420, to a particular radio-frequency powerlevel as well as a particular fluid flow setting. In this manner, thefluid flow from device 10 for a particular radio-frequency power leveland fluid level may be better controlled and a greater power level wouldnot be available for selection.

Exemplary functional relationships of fluid flow rate Q in units ofcubic centimeters per minute (cc/min) on the Y-axis, and the bipolar RFpower setting Ps in units of watts on the X-axis as shown in FIG. 42.The relationships may be engineered to inhibit undesirable effects suchas tissue desiccation, electrode sticking, smoke production and charformation, while at the same time not providing a fluid flow rate Q at acorresponding RF power setting Ps which is so great as to provide toomuch electrical dispersion and cooling at the electrode/tissueinterface. While not being bound to a particular theory, a more detaileddiscussion on how the fluid flow rate interacts with the radio frequencypower, modes of heat transfer away from the tissue, fractional boilingof the fluid and various control strategies may be found in U.S.Publication No. 200110032002, published Oct. 18, 2001, assigned to theassignee of the present invention and hereby incorporated by referencein its entirety to the extent it is consistent.

As shown in FIG. 42, exemplary relationships QL, QM and QH areconfigured to increase the fluid flow rate Q linearly with an increasingradio-frequency power level setting Ps for each of three fluid flow ratesettings of low, medium and high, respectively. Conversely, therelationships QL, QM and QH are configured to decrease the fluid flowrate Q linearly with a decrease RF power setting Ps for each of threefluid flow rate settings of low, medium and high, respectively.Accordingly, the data stored in the memory 26 of device 10 is to set aspeed of the pump assembly 422 for a particular radio-frequency powerlevel and a particular fluid flow level such that the throughput offluid delivery apparatus 420 corresponds to the relationships providedin FIG. 42. The data may be stored in the form of equations, or asnumerical data points as part of a database look-up table.

An exemplary bipolar radio-frequency power output curve ofelectrosurgical unit 300 is shown in FIG. 43. Impedance Z, shown inunits of ohms on the X-axis and output power Po is shown in units ofwatts on the Y-axis. In the illustrated embodiment, the bipolarelectrosurgical power (RF) is set to 300 watts. As shown in the figure,for an RF power setting Ps of 300 watts, the output power Po will remainconstant with the set RF power Ps as long as the impedance Z staysbetween the low impedance cut-off of 30 ohms and the high impedancecut-off of 120 ohms. Below an impedance Z of 30 ohms, the output powerPo will decrease as shown by the low impedance ramp. Above an impedanceZ of 120 ohms, the output power Po will also decrease as shown by thehigh impedance ramp.

With respect to monopolar power output, an exemplary monopolarradio-frequency power output curve of electrosurgical unit 300 is shownin FIG. 44. Impedance Z, shown in units of ohms on the X-axis and outputpower Po is shown in units of watts on the Y-axis. In the illustratedembodiment, the bipolar electro surgical power (RF) is set to 300 watts.As shown in the figure, for an RF power setting Ps of 300 watts, theoutput power Po will remain constant with the set RF power Ps as long asthe impedance Z stays between the low impedance cut-off of 200 ohms andthe high impedance cut-off of 800 ohms. Below an impedance Z of 200ohms, the output power Po will decrease as shown by the low impedanceramp.

Above an impedance Z of 800 ohms, the output power Po will also decreaseas shown by the high impedance ramp.

Having discussed a system in which electrosurgical device 10 andelectrosurgical unit 300 may be arranged and used, attention will nowfocus on an application of electro surgical device 10 to treatingtissue. As shown in FIG. 45, one way in which device 10 with hand-piece12 may be used is with the longitudinal axis of electrodes 180 a, 180 bvertically orientated, and the distal end portion 186 a, 186 b ofelectrodes 180 a, 180 b laterally spaced adjacent tissue surface 522 oftissue 520. When device 10 is used in this manner, electrodes 180 a, 180b are connected to electrosurgical unit 300 and receive bipolar radiofrequency power which forms an alternating current electrical field 528in tissue 520 located between electrodes 180 a, 180 b. In the presenceof alternating current, the electrodes 180 a, 180 b alternate polaritybetween positive and negative charges with current flow from thepositive to negative charge. Without being bound to a particular theory,heating of the tissue is performed by electrical resistance heating.

Fluid 502, in addition to providing an electrical coupling between thedevice 10 and tissue 520, lubricates surface 522 of tissue 520 andfacilitates the movement of electrodes 180 a, 180 b across surface 522of tissue 520. During movement of electrodes 180 a, 180 b, electrodes180 a, 180 b typically slide across the surface 522 of tissue 520.Typically the user of device 10 slides electrodes 180 a, 180 b acrosssurface 522 of tissue 520 back and forth with a painting motion whileusing fluid 502 as, among other things, a lubricating coating. Thethickness of the fluid 502 between the distal end portions 186 a, 186 bof electrodes 180 a, 180 b and surface 522 of tissue 520 at the outeredge of couplings 524 a, 524 b may be in the range of and any incrementbetween 0.05 mm to 1.5 mm. Also, in certain embodiments, the distal endportion 186 a, 186 b of electrodes 180 a, 180 b may contact surface 522of tissue 520 without any fluid 502 in between.

As shown in FIG. 45, fluid 502 expelled from fluid outlets 208 a/210a/212 a/214 a and 208 b 1210 b/212 b 1214 b may form into droplets 526a, 526 b which flow distally on electrodes 180 a, 180 b. As shown inFIG. 45, droplets 526 a, 526 b may form at varying times from fluid 502expelled from anyone of the fluid outlets. Also, fluid 502 may beexpelled in varying quantity from each of the fluid outlets, dependingon, for example, device orientation, pressure, flow rate and varyingfluid outlet sizes. With use of device 10, the size of droplets 526 a,526 b may also vary due to changes in the surface finish of theelectrodes 180 a, 180 b, for example, as a result of being contaminatedby blood and tissue.

As shown in FIG. 45, fluid couplings 524 a, 524 b comprise discrete,localized webs and more specifically comprise triangular shaped webs orbead portions providing a film of fluid 502 between surface 522 oftissue 520 and electrodes 180 a, 180 b. When the user of electrosurgicaldevice 10 places electrodes 180 a, 180 b at a tissue treatment site andmoves electrodes 180 a, 180 b across the surface 522 of the tissue 520,fluid 502 is expelled from fluid outlets 208 a/210 a/212 a/214 a and 208b 1210 b/212 b 1214 b around the surfaces of electrodes 180 a, 180 b andonto the surface 522 of the tissue 520 via couplings 524 a, 524 b. Atthe same time, radio-frequency electrical energy, shown by electricalfield lines 528, is provided to tissue 520 at tissue surface 522 andbelow tissue surface 522 into tissue 520 through fluid couplings 524 a,524 b. As shown in FIG. 46, hand-piece 12 of device 10 may be used tocut tissue by applying either cutting edge 198 a or 198 b to tissue 520,depending which electrode 180 a, 180 b is utilized.

With regards to hand-piece 12 a, as shown in FIG. 47, when the user ofelectro surgical device 10 places electrodes 180 a, 180 b at a tissuetreatment site and moves electrodes 180 a, 180 b across the surface 522of the tissue 520, fluid 502 is expelled from fluid outlets 240 a and240 b onto surfaces 222 a, 222 b of electrodes 180 a, 180 b and onto thesurface 522 of the tissue 520 via couplings 524 a, 524 b. At the sametime, radio-frequency electrical energy, shown by electrical field lines528, is provided to tissue 520 at tissue surface 522 and below tissuesurface 522 into tissue 520 through fluid couplings 524 a, 524 b. Inthis manner, device 10 may be used to seal and/or shrink blood vesselsin tissue 520 to inhibit blood loss therefrom. Similar to FIG. 46,hand-piece 12 a of device 10 may be used to cut tissue by applyingeither cutting edge 226 a or 226 b to tissue 520, depending whichelectrode 180 a, 180 b is utilized.

Device 10 may be used to perform a solid organ resection such as a liverresection. Edge 198 a or 198 b may be first used to score the outercapsule of the liver along the planned line of resection. Thereafter,the distal end portions 186 a, 186 b of electrodes 180 a, 180 b may bemoved back and forth along the line, with radio frequency power and theflow of fluid on, resulting in coagulation of the liver parenchymabeneath the scored capsule. As the tissue is coagulated under and aroundthe electrode surfaces, the electrodes 180 a, 180 b may be used toseparate and blunt dissect the coagulated parenchyma and enter theresulting crevice. As the distal end portions 186 a, 186 b of electrodes180 a, 180 b treat the parenchyma, the treated parenchyma loosesintegrity and becomes easier to separate, either alone or in conjunctionwith separation force applied by electrodes 180 a, 180 b from the userof the device.

Blunt dissection of the coagulated parenchyma IS performed by continuousabrading or splitting apart of the parenchyma with substantially thesame back and forth motion as coagulation and with the device 10 beingheld substantially in the same orientation as for coagulation of theliver parenchyma. However, with blunt dissection, the surgeon typicallyapplies more force to the tissue. In various embodiments, once the liverparenchyma is coagulated, blunt dissection may be performed with orwithout monopolar radio frequency power (i.e., on or off) and/or with orwithout the presence of fluid from device 10. Additionally oralternatively, the tissue on opposing sides of the line of resection maybe placed into tension perpendicular to the line of resection tofacilitate resection. Furthermore, resection may also be accomplished bysharp dissection with edge 198 a or 198 b of electrodes 180 a, 180 b.Thus, with device 10, a surgeon may perform a resection procedure in anumber of different ways.

As the parenchyma is resected, blood vessels within the parenchyma maybe uncovered which extend across or transverse the line of resection.Device 10 may be used to shrink and seal these vessels by heating andshrinking the collagen contained in the walls of the vessels thusdecreasing the diameter of the lumen of these vessels. For vessels witha diameter too large to completely occlude the lumen, the vessels maytied with suture on each side of the line of resection and thereaftersevered therebetween. If such vessels are not first uncovered byremoving the surrounding parenchyma tissue and without being severed,they may bleed profusely and require much more time to stop thebleeding. Consequently, it may be desirable to avoid separation by sharpdissection in situations where large vessels are not first uncovered andexposed.

This technique can also be used on other parenchymal organs such as thepancreas, the kidney, and the lung. In addition, it may also be usefulon muscle tissue and subcutaneous fat. Its use can also extend totumors, cysts or other tissue masses found in the urological orgynecological areas. It would also enable the removal of highlyvascularized tumors such as hemangiomas.

The devices disclosed herein are particularly useful as non-coaptivedevices that provide cutting of tissue, as well as coagulation,hemostasis and sealing of tissue to inhibit blood and other fluid lossduring surgery. In other words, grasping of the tissue is not necessaryto shrink, coagulate, cut and seal tissue against blood loss, forexample, by shrinking collagen and associated lumens of blood vessels(e.g., arteries, veins) to provided the desired hemostasis of thetissue. Furthermore, the control system of the electro surgical unit 300is not necessarily dependent on tissue feedback such as temperature orimpedance to operate. Thus, the control system of electrosurgical unit300 may be open loop with respect to the tissue which simplifies use.

Device 10 disclosed herein are particularly useful to surgeons toachieve hemostasis after cutting through soft tissue, as part of hip orknee arthroplasty. The distal end portions 186 a, 186 b can be paintedover the raw, oozing surface 522 of tissue 520 to seal the tissue 520against bleeding, or focused on individual larger bleeding vessels tostop vessel bleeding. As part of the same or different procedure, device10 is also useful to stop bleeding from the surface of cut bone, orosseous, tissue as part of any orthopaedic procedure that requires boneto be cut.

As is well known, bone, or osseous tissue, is a particular form of denseconnective tissue consisting of bone cells (osteocytes) embedded in amatrix of calcified intercellular substance. Bone matrix mainly containscollagen fibers and the minerals calcium carbonate, calcium phosphateand hydroxyapatite. Among the many types of bone within the human bodyare compact bone and cancellous bone. Compact bone is hard, dense bonethat forms the surface layers of bones and also the shafts of longbones. It is primarily made of haversian systems which are covered bythe periosteum. Compact bone contains discrete nutrient canals throughwhich blood vessels gain access to the haversian systems and the marrowcavity of long bones. For example, Volkmann's canals which are smallcanals found in compact bone through which blood vessels pass from theperiosteum and connect with the blood vessels of haversian canals or themarrow cavity. Devices 30 a-30 e disclosed herein may be particularlyuseful to treat compact bone and to provide hemostasis and seal bleedingvessels (e.g. by shrinking to complete close) and other structuresassociated with Volkmann's canals and haversian systems.

In contrast to compact bone, cancellous bone is spongy bone and formsthe bulk of the short, flat, and irregular bones and the ends of longbones. The network of osseous tissue that makes up the cancellous bonestructure comprises many small trabeculae, partially enclosing manyintercommunicating spaces filled with bone marrow. Consequently, due totheir trabecular structure, cancellous bones are more amorphous thancompact bones, and have many more channels with various blood cellprecursors mixed with capillaries, venules and arterioles. Device 10disclosed herein may be particularly useful to treat cancellous bone andto provide hemostasis and seal bleeding structures such as the abovemicro-vessels (i.e. capillaries, venulesand arterioles) in addition toveins and arteries. Device 10 may be particularly useful for use duringorthopedic knee, hip, shoulder and spine procedures (e.g. arthroplasty).

During a knee replacement procedure, the condyle at the distal epiphysisof the femur and the tibial plateau at the proximal epiphysis of thetibia are often cut and made more planer with saw devices to ultimatelyprovide a more suitable support structure for the femoral condylarprosthesis and tibial prosthesis attached thereto, respectively. Thecutting of these long bones results in bleeding from the cancellous boneat each location. In order to seal and arrest the bleeding from thecancellous bone which has been exposed with the cutting of epiphysis ofeach long bone, bipolar device 10 may be utilized. Thereafter, therespective prostheses may be attached.

Turning to a hip replacement procedure, the head and neck of the femurat the proximal epiphysis of the femur may be removed, typically bycutting with a saw device, and the intertrochantic region of the femurmay be made more planer to provide a more suitable support structure forthe femoral stem prosthesis subsequently attached thereto. With respectto the hip, a ball reamer may be used to ream and enlarge the acetabulumof the innominate (hip) bone to accommodate the insertion of anacetabular cup prosthesis therein, which will provide the socket intowhich the head of the femoral stem prosthesis fits. The cutting of thefemur and reaming of the hip bone typically results in bleeding from thecancellous bone at each location. In order to seal and arrest thebleeding from the cancellous bone which has been cut and exposed, device10 may be utilized. Thereafter, as with the knee replacement, therespective prostheses may be attached.

Device 10 may be utilized for treatment of connective tissues, such asfor shrinking intervertebral discs during spine surgery. Intervertebraldiscs are flexible pads of fibrocartilaginous tissue tightly fixedbetween the vertebrae of the spine. The discs comprise a flat, circularcapsule roughly an inch in diameter and about 0.25 inch thick, made of atough, fibrous outer membrane called the annulus fibrosus, surroundingan elastic core called the nucleus pulposus.

Under stress, it is possible for the nucleus pulposus to swell andherniate, pushing through a weak spot in the annulus fibrosus membraneof the disc and into the spinal canal. Consequently, all or part of thenucleus pulposus material may protrude through the weak spot, causingpressure against surrounding nerves which results in pain andimmobility.

Device 10 may be utilized to shrink protruding and herniatedintervertebral discs which, upon shrinking towards normal size, reducesthe pressure on the surrounding nerves and relieves the pain andimmobility. Device 10 may be applied via posterior spinal access undersurgeon control for focal shrinking of the annulus fibrosus membrane.

Where an intervertebral disc cannot be repaired and must be removed aspart of a discectomy, device 10 may be particularly useful to seal andarrest bleeding from the cancellous bone of opposing upper and lowervertebra surfaces (e.g. the cephalad surface of the vertebral body of asuperior vertebra and the caudad surface of an inferior vertebra). Wherethe disc is removed from the front of the patient, for example, as partof an anterior, thoracic spine procedure, device 10 may also beparticularly useful to seal and arrest bleeding from segmental vesselsover the vertebral body.

Device 10 may be utilized to seal and arrest bleeding of epidural veinswhich bleed as a result of the removal of tissue around the duralmembrane during, for example a laminectomy or other neurosurgicalsurgery. The epidural veins may start bleeding when the dura isretracted off of them as part of a decompression. Also during alaminectomy, device 10 may be used to seal and arrest bleeding from thevertebral arch and, in particular the lamina of the vertebral arch.

As established above, device 10 of the present invention may inhibitsuch undesirable effects of tissue desiccation, electrode sticking, charformation and smoke generation. The use of the disclosed devices canresult in significantly lower blood loss during surgical procedures.Such a reduction in blood loss can reduce or eliminate the need forblood transfusions, and thus the cost and negative clinical consequencesassociated with blood transfusions, such as prolonged hospitalization.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications can be made therein without departing from the spirit ofthe invention and the scope of the appended claims. The scope of theinvention should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.Furthermore, it should be understood that the appended claims do notnecessarily comprise the broadest scope of the invention which theApplicant is entitled to claim, or the only manner(s) in which theinvention may be claimed, or that all recited features are necessary.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications can be made therein without departing from the spirit ofthe invention and the scope of the appended claims. The scope of theinvention should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.Furthermore, it should be understood that the appended claims do notnecessarily comprise the broadest scope of the invention which theApplicant is entitled to claim, or the only manner(s) in which theinvention may be claimed, or that all recited features are necessary.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications can be made therein without departing from the spirit ofthe invention and the scope of the appended claims. The scope of theinvention should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.Furthermore, it should be understood that the appended claims do notnecessarily comprise the broadest scope of the invention which theApplicant is entitled to claim, or the only manner(s) in which theinvention may be claimed, or that all recited features are necessary.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

The present invention has been described above with the aid offunctional building blocks illustrating the implementation of specifiedfunctions and relationships thereof. The boundaries of these functionalbuilding blocks have been arbitrarily defined herein for the convenienceof the description. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

The claims in the instant application are different than those of theparent application or other related applications. The Applicanttherefore rescinds any disclaimer of claim scope made in the parentapplication or any predecessor application in relation to the instantapplication. The Examiner is therefore advised that any such previousdisclaimer and the cited references that it was made to avoid, may needto be revisited. Further, the Examiner is also reminded that anydisclaimer made in the instant application should not be read into oragainst the parent application.

The invention claimed is:
 1. An electrosurgical system comprising: anelectrosurgical device comprising a memory and a blade including a firstelectrode and a second electrode, each of the first electrode and thesecond electrode having a noncircular cross-section defining concavesides converging into a lateral cutting edge, wherein the concave sidesdefine fluid outlets in proximity to the lateral cutting edge; and anelectrosurgical unit comprising a touchscreen graphical user interface(GUI) and a radio-frequency power generator configured to outputmonopolar radio-frequency power and bipolar radio frequency power and apump configured to control fluid flow in the fluid delivery tubing, theelectrosurgical unit coupled with the electrosurgical device so as tosimultaneously provide radio frequency power generated by theradio-frequency power generator to at least one of the first electrodeor the second electrode and fluid pumped by the pump to the fluiddelivery tubing, wherein the pump has a plurality of fluid flowsettings, and a fluid flow at any of the plurality of fluid flowsettings varies according to a level of radio-frequency power providedby the radio-frequency power generator, the electrosurgical unit furthercomprising an electrosurgical unit memory and an internal countdownclock, wherein the electrosurgical unit is configured to receive astream of serial data from the memory of the electrosurgical device,wherein the stream of serial data comprises a unique identifier of theelectrosurgical device, and wherein the time of first radio-frequencyactivation of the electrosurgical device is stored in theelectrosurgical unit memory and applied to the internal countdown clockdenoting a fixed time period of use of the electrosurgical device. 2.The electrosurgical system of claim 1, wherein the plurality of fluidflow settings comprise a low fluid flow setting, a medium fluid flowsetting, and a high fluid flow setting.
 3. The electrosurgical system ofclaim 2, wherein a fluid flow rate at any one of the low, medium or highfluid flow settings increases linearly with an increasing level ofradio-frequency power provided by the radio-frequency power generator tothe first electrode and the second electrode.
 4. The electrosurgicalsystem of claim 2, wherein a fluid flow rate at any one of the low,medium or high fluid flow settings decreases linearly with an decreasinglevel of radio-frequency power provided by the radio-frequency powergenerator to the first electrode and the second electrode.
 5. Theelectrosurgical system of claim 2, wherein the electrosurgical unit setsa speed of the pump based on which one of the lower, medium or highfluid flow settings is selected and a level of the radio frequency powerprovided by the radio-frequency power generator to the first electrodeand the second electrode.
 6. The electrosurgical system of claim 1,wherein the electrosurgical unit is configured to receive and read astream of serial data from the memory, wherein the stream of serial datacomprises data that sets a speed of the pump for a particularradio-frequency power level and a particular fluid flow level.
 7. Theelectrosurgical system of claim 1, wherein the fluid flow at any of theplurality of fluid flow settings varies according to the level ofradio-frequency power provided by the radio-frequency power generator toinhibit at least one of tissue desiccation, electrode sticking, smokeproduction, or char production.
 8. The electrosurgical system of claim1, wherein the fluid flow at any of the plurality of fluid flow settingsvaries according to the level of radio-frequency power provided by theradio-frequency power generator to control electrical dispersion andcooling at an electrode/tissue interface.
 9. The electrosurgical systemof claim 1, wherein a relationship between the fluid flow at any of theplurality of fluid flow settings and the level of radio-frequency powerprovided by the radio-frequency power generator is stored in a memory ofthe electrosurgical system as an equation or as numerical data points ina database look-up table.
 10. The electrosurgical system of claim 1,wherein the memory of the electrosurgical device comprises a defaultsetting for a radio-frequency power level and a fluid flow setting. 11.The electrosurgical system of claim 10, wherein the memory of theelectrosurgical device comprises operating parameters providing a rangeof radio-frequency power levels defined by a minimum radio-frequencypower level and a maximum radio-frequency power level, and range offluid flow levels defined by a minimum fluid flow level and a maximumfluid flow level.